Canon Medical Systems Corporation November 2, 2018

Orlando Tadeo, Jr.

Sr. Manager, Regulatory Affairs
2441 Michelle Drive
TUSTIN, CA 92780

Re: K182596
Trade/Device Name: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: September 18, 2018
Received: September 20, 2018

Dear Orlando Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.03.01
Silver Spring, MD 20993
www.fda.gov
K182596 - Orlando Tadeo Page 2

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).

Sincerely,

For
Robert A
A. Ochs,
h Ph.D.
D
Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.

510(k) Number (if known)

.
Device Name

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

Indications for Use (Describe)

The Diagnostic Ultrasound System Xario200G Model CUS-X200G and Xario100G Model CUS-X100G are indicated for
the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image
information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal),
laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal
(conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

Type of Use (Select one or both, as applicable)

; Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: __________________

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal N N N N 2 N N N N 4,5,6,7,8,9,11,12
Abdominal N N N N N 2,3 N N N N 4,5,6,7,8,9,11,12,14
Intra-operative (Abdominal) N N N N 2 N N N 5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic N N N N 2 N N N 5,7
Pediatric N N N N N 2,3 N N N N 4,5,6,7,8,9,11,12
Small Organ (Note 1) N N N N 2 N N N 4,5,6,7,8,9,10,11,12
Neonatal Cephalic N N N N N 2,3 N N N 5,6,7,8,11
Adult Cephalic N N N N N 3 N N N 7
Trans-rectal N N N N 2 N N N N 4,5,6,7,8,9,12
Trans-vaginal N N N N 2 N N N N 4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional) N N N N 2 N N N 4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial) N N N N 2 N N N 4,5,6,7,8,9,10,11,12
Intravascular
Other (Specify)
Cardiac Adult N N N N N 3 N N N 4, 7, 13
Cardiac Pediatric N N N N N 3 N N N 4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac) N N N N N 3 N 4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel N N N N N 2 N N N 4,5,6,7,8,9,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PSU-25BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P P 3 P P P 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 P P P 7
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P P P 7
Adult Cephalic P P P P P 3 P P P 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P P 4, 7, 13
Cardiac Pediatric P P P P P 3 P P P 4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PSU-30BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P P 3 P P P 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 P P P 7
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P P P 7
Adult Cephalic P P P P P 3 P P P 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P P 4, 7, 13
Cardiac Pediatric P P P P P 3 P P P 4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PSU-50BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P P 3 P P P 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 P P P 7
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P P P 7
Adult Cephalic P P P P P 3 P P P 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P P 4, 7, 13
Cardiac Pediatric P P P P P 3 P P P 4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PSU-70BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P P 3 P P P 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 P P P 7
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P P P 7
Adult Cephalic P P P P P 3 P P P 7
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P P 4, 7, 13
Cardiac Pediatric P P P P P 3 P P P 4, 7, 13
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-375BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal P P P P 2 P P P 4,5,6,7,8,9,11,12
Abdominal P P P P 2 P P P 4,5,6,7,8,9,11,12,14
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P 4,5,6,7,8,9,11,12
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-382BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal P P P P 2 P P P 5,6,7,8,11
Abdominal P P P P 2 P P P 5,6,7,8,11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P 5,6,7,8,11
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-674BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal P P P P 2 P P P 5,6,7,8,11,12
Abdominal P P P P 2 P P P 5,6,7,8,11,12
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P 5,6,7,8,11,12
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-674MV

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal P P P P 2 P P P P 5,6,7,8
Abdominal P P P P 2 P P P P 5,6,7,8
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P P 5,6,7,8
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-712BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic 2D [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P 2 P P P 5,6,7,8,11
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P 5,6,7,8,11
Small Organ (Note 1)
Neonatal Cephalic P P P P 2 P P P 5,6,7,8,11
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-745BTF

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P 2 P P P 5,6,7,8,11
Intra-operative (Abdominal) P P P P 2 P P P 5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-745BTH

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P 2 P P P 5,6,7,8,11
Intra-operative (Abdominal) P P P P 2 P P P 5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-745BTV

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal P P P P 2 P P P 5,6,7,8,11
Intra-operative (Abdominal) P P P P 2 P P P 5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 5,6,7,8,11
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-681MVL

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P P 5,6,7,8,12
Trans-vaginal P P P P 2 P P P P 5,6,7,8,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-770ST

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P 4,5,6,7,8,9
Trans-vaginal P P P P 2 P P P 4,5,6,7,8,9
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-781VT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P 4,5,6,7,8,9,12
Trans-vaginal P P P P 2 P P P 4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVU-781VTE

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P 4,5,6,7,8,9,12
Trans-vaginal P P P P 2 P P P 4,5,6,7,8,9,12
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PVL-715RS

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P 5,6,7,8,12
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PLU-704BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 5,6,7,8,10,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional) P P P P 2 P P P 5,6,7,8,10,11,12
Musculo-skeletal (Superficial) P P P P 2 P P P 5,6,7,8,10,11,12
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P 5,6,7,8,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PLU-1005BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PLU-1202BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal) P P P P 2 P P P 5,6,7,8,11
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 4,5,6,7,8,9,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional) P P P P 2 P P P 4,5,6,7,8,9,11,12
Musculo-skeletal (Superficial) P P P P 2 P P P 4,5,6,7,8,9,11,12
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P 4,5,6,7,8,9,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PLU-1204BT

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other [Note]
(Tracks 3) Doppler (Specify) * Dynamic
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Musculo-skeletal (Superficial) P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P 4,5,6,7,8,9,10,11,12
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PET-512MC

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P 3 P 4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PET-512MD

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P 3 P 4, 7, 13
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PET-805LA

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Dynamic Power CHI 4D Other [Note]
(Tracks 3) Doppler (Specify) * Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic P P P P 2 P P P 5,7
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PC-20M

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P
Cardiac Pediatric P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

Canon Medical Systems USA, Inc. 510(k) Premarket Notification
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

System: Xario200G and Xario100G, Software V1.1

Transducer: PC-50M

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application Mode of Operation

Specific B M PWD CWD Color Combined THI Advanced Power CHI㻌 4D Other
(Tracks 3) Doppler (Specify) * Dynamic [Note]
Flow
Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P
Cardiac Pediatric P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K172276

Note 1 Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI
Note 5 ApliPure
Note 6 ApliPure Plus
Note 7 Precision Imaging
Note 8 Differential THI
Note 9 Elastography
Note 10 BEAM
Note 11 Smart 3D
Note 12 SMI
Note 13 2D Wall Motion Tracking
Note 14 Shear Wave

Prescription Use Only (Per 21 CFR 801.109)

 K182596

510(k) SUMMARY 

1. SUBMITTER’S NAME:
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara‐shi, Tochigi‐ken, Japan 324‐8550

2. OFFICIAL CORRESPONDENT
Naofumi Watanabe

3. ESTABLISHMENT REGISTRATION:
9614698

4. CONTACT PERSON:
Orlando Tadeo, Jr.
Sr. Manager, Regulatory Affairs
Canon Medical Systems USA, Inc
2441 Michelle Drive
Tustin, CA 92780
(714) 669‐7459

5. DATE PREPARED:
September 7, 2018

6. DEVICE NAME:
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

7. TRADE NAME(S):
Diagnostic Ultrasound System Xario200G Model CUS‐X200G
Diagnostic Ultrasound System Xario100G Model CUS‐X100G

8. COMMON NAME:
System, Diagnostic Ultrasound

2441 Michelle Drive, Tustin, CA 92780 PHONE: 800‐421‐1968   

https://us.medical.canon 

Page 1 of 4 
 

9. DEVICE CLASSIFICATION: 
Class II  
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90‐IYN [per 21 CFR 892.1550] 
Ultrasonic Pulsed Echo Imaging System – Product Code: 90‐IYO [per 21 CFR 892.1560] 
Diagnostic Ultrasonic Transducer – Product Code: 90‐ITX [per 21 CFR 892.1570] 
 
10. PREDICATE DEVICE: 
Product  Marketed by  510(k) Number  Clearance Date 
Xario 200 Diagnostic  Canon Medical 
K172276  December 12, 2017 
Ultrasound System V6.0  Systems USA, Inc 
 
11. REASON FOR SUBMISSION: 
New device 
 
12. DEVICE DESCRIPTION:   
The Xario200G Model CUS‐X200G and Xario100G Model CUS‐X100G are mobile diagnostic ultrasound 
systems.  These systems are Track 3 devices that employ a wide array of probes including flat linear 
array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 
12 MHz. 
 
13. INDICATIONS FOR USE:  
The Diagnostic Ultrasound System Xario200G Model CUS‐X200G and Xario100G Model CUS‐X100G 
are indicated for the visualization of structures, and dynamic processes with the human body using 
ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, 
abdominal, intra‐operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult 
cephalic, trans‐rectal, trans‐vaginal, musculo‐skeletal (conventional), musculo‐skeletal(superficial), 
cardiac adult, cardiac pediatric, trans‐esoph(cardiac) and peripheral vessel.   
 
14. SUBSTANTIAL EQUIVALENCE:  
This device is substantially equivalent to the Xario200 V6.0 Diagnostic Ultrasound System, 510(k) 
cleared under K172276, marketed by Canon Medical Systems USA, Inc.  The Xario200G and 
Xario100G, Software V1.1 Diagnostic Ultrasound System functions in a manner similar to and is 
intended for the same use as the predicate devices referenced within this submission.  The subject 
device is a compact diagnostic ultrasound system that implements the latest technologies.   
 
 
 
 
 
 

 
Page 2 of 4 
 

  Xario200G/Xario100G  Xario200  Comments 

Model CUS‐X200G  Model TUS‐X200 v6.0 
Model CUS‐X100G, v1.1 
510(K) Control Number  This Submission (Subject)  K172276   
Scanning Method  Electronic Convex,  Electronic Convex,  Same 
Electronic Sector,  Electronic Sector, 
Electronic  Electronic 
Linear/Trapezoid, Pencil  Linear/Trapezoid, Pencil 
Probe Selector  A/B/C Channels  A/B/C Channels  Same 
3 connections and Pencil  3 connections and Pencil 
  Xario200G/Xario100G  Xario200  Comments 
Model CUS‐X200G  Model TUS‐X200 v6.0 
Model CUS‐X100G, v1.1 
B‐Mode Depth  1cm (min.), 40 cm (max.)  1cm (min.), 40 cm (max.)  Same 
Transmission/Reception       
Circuitry       
Beam Formation Control  Digital  Digital  Same 
Processing  Parallel processing  Parallel processing  Same 
Summation  Quad Processing  Quad Processing  Same 
Maximum Transmission  128 Channels (Xario200G)  128 Channels  Same for 
Channels  64 Channels (Xario100G)  Xario200G 
Transmission Frequency  Multiple frequencies are  Multiple frequencies are  Same 
selectable  selectable 
Observation Monitor  21.5‐inch LCD  19‐inch LCD  Change 
(LED backlight)  (LED backlight) 
Reference signal: ECG       
Wired  Yes  Yes  Same 
Wireless  Yes (Xario200G) / No  No  Change 
(Xario100G) 
Foot switch        
Wired  Yes  Yes  Same 
Wireless  Yes (Xario200G) / No  No  Change 
(Xario100G) 
Battery pack  Yes  No  Change 
Mounting kit for Battery  Yes (Xario200G) / No  No  Change 
pack  (Xario100G) 
 
15. SAFETY:  
The device is designed and manufactured under the Quality System Regulations as outlined in 21 
CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the 
IEC60601‐1, IEC 60601‐1‐2, IEC 60601‐2‐37, IEC 62304, AIUM RTD2‐2004 Output Display and ISO 
10993‐1 standards.  

 
 
Page 3 of 4 
 

16. TESTING 
Risk Analysis, Verification/Validation testing conducted which are included in this submission 
demonstrates that the requirements for the features have been met.   
 
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, 
“Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices 
Document” issued on May 11, 2005, is also included as part of this submission.   
 
Additionally, testing of this device was conducted in accordance with the applicable standards 
published by the International Electrotechnical Commission (IEC) for Medical Devices.   
 
No clinical studies were required to demonstrate safety and efficacy of the Xario200G/Xario100G 
systems. 
 
17. CONCLUSION 
The Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System are substantially 
equivalent to the predicate device.  The subject devices function in a manner similar to and is 
intended for the same use as the predicate device, as described in the labeling.  Based upon the 
successful completion of software validation, application of risk management and design controls, it 
is concluded that this device is safe and effective for its intended use.  

 
Page 4 of 4