DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

__________________________________________________________________________________________________________________________

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Siemens Medical Solutions USA, Inc. November 22, 2016

Ə0V'HQLVH$GDPV
Regulatory Affairs Specialist
40 Liberty Boulevard, 65-1A
MALVERN PA 19355

Re: K162971
Trade/Device Name: Multix Fusion Max
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: II
Product Code: KPR
Dated: October 21, 2016
Received: October 25, 2016

Dear Ms. Adams:

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. 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 801); medical device reporting (reporting of medical
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2— Ms. Denise Adams

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH’s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs, Ph.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: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K162971
Device Name
Multix Fusion Max

Indications for Use (Describe)

Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion Max
enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on
pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
The Multix Fusion Max system is not meant for mammography.

Multix Fusion Max uses a mobile(wired), or a fixed (integrated) or wireless digital detector for generating diagnostic
images by converting x-rays into image signals. The Multix Fusion Max is also designed to be used with conventional
film/screen or Computed Radiography (CR) cassettes.

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 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Confidential 24
 Healthcare

510(k) Summary: Multix Fusion Max

Company: Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355

Date Prepared: November 21, 2016

This 510(k) summary of safety and effectiveness information is being submitted in

accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information
Importer / Distributor
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355
Establishment Registration Number
2240869

Location of Manufacturing Site

Siemens Shanghai Medical Equipment Ltd.
278 Zhou Zhu Road, Shanghai
201318, China
Establishment Registration Number
3003202425

Siemens Healthcare GmbH, Business Unit XP

Siemensstrasse 1
Forchheim, Germany 91301
Establishment Registration Number:
3004977335

2. Contact Person
Denise Adams, RAC
Regulatory Affairs Specialist
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355
610-448-6139
[email protected]
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Phone: +1-888-826-9702
Malvern, PA 19355-9998 usa.siemens.com/healthcare
USA
 3. Device Name and Classification
Trade Name: Multix Fusion Max
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Classification Regulation: 21 CFR §892.1680
Device Class: Class II
Product Code: KPR

4. Legally Marketed Predicate Devices

Primary Predicate
Trade Name: Multix Fusion
510(k) #: K142049
Clearance Date: December 18, 2014
_ Classification Name: Stationary X-Ray System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1680
Device Class: Class II
Product Code: KPR

Reference Predicate
Trade Name: YSIO Max
510(k) #: K133259
Clearance Date: January 24, 2014
Classification Name: Stationary X-Ray System
Classification Panel: Radiology
CFR Section: 21 CFR §892.1680
Device Class: Class II
Product Code: KPR

5. Device Description
The Multix Fusion Max Radiography X-ray system is a modular system of x-ray components
(ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable
wireless and integrated detectors) same as the predicate the Multix Fusion. This 510(k)
submission describes modifications to the predicate device the Multix Fusion cleared via
K142049.

The following modifications have been made to the cleared predicate device and the system
will be rebranded the Multix Fusion Max:
 Hardware
The following components are being integrated into the system: the Pixium 3543 EZh wireless
detector, the Pixium 2430 EZ wireless detector; the Pixium 4343RCE fixed detector, a new
wireless Bucky wall stand with motorized height adjustment, a new table that has a charging
tray and a manual Bucky tray, and a new 92-line grid with a 13:1 ratio.

Software
The operating system is being upgraded from Windows XP to Windows 7 and the software
version will now be VE21.

6. Indication for Use

Multix Fusion Max system is a radiographic system used in hospitals, clinics, and medical
practices. Multix Fusion Max enables radiographic exposures of the whole body including:
skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric
_ patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
The Multix Fusion Max system is not meant for mammography.
Multix Fusion Max uses a mobile (wired), or a fixed (integrated) or wireless digital detector
for generating diagnostic images by converting x-rays into image signals. The Multix Fusion
Max is also designed to be used with conventional film/screen or Computed Radiography (CR)
cassettes.

7. Substantial Equivalence
The Multix Fusion Max is a modification to the primary predicate device the Multix Fusion
cleared via K142049. The Multix Fusion Max utilizes the same wireless detectors as the
reference device the Ysio Max cleared via K133259. It is within the same classification
regulation for the same indications for use and the same mechanical design as the predicate
devices. The Multix Fusion Max is substantially equivalent to the predicate devices and
documentation is provided to support a claim of substantial equivalence.

Comparison of Indications for Use

Multix Fusion Max Multix Fusion K142049 Comparison
(subject) (primary predicate) Results

The Multix Fusion Max The Multix Fusion system Same

Indications system is a radiographic is a radiographic system
for Use system used in hospitals, used in hospitals, clinics,
clinics, and medical and medical practices.
practices. Multix Fusion Max Multix Fusion enables
enables radiographic radiographic exposures of
exposures of the whole body the whole body including:
including: skull, chest, skull, chest, abdomen, and
abdomen, and extremities extremities and may be
and may be used on used on pediatric, adult and
pediatric, adult and bariatric bariatric patients.
patients. Exposures may be Exposures may be taken
taken with the patient sitting, with the patient sitting,
 standing, or in the prone standing, or in the prone
position. The Multix Fusion position. The Multix
Max system is not meant for Fusion system is not meant
mammography. for mammography.
The Multix Fusion uses a The Multix Fusion uses a
mobile (wired), or fixed mobile (wired), or fixed
(integrated) or wireless (integrated) or wireless
digital detector for digital detector for
generating diagnostic images generating diagnostic
by converting x-rays into images by converting x-
image signals. rays into image signals.

The Multix Fusion is also The Multix Fusion is also

designed to be used with designed to be used with
conventional film/ screen or conventional film/ screen
Computed Radiography or Computed Radiography
_
(CR) cassettes. (CR) cassettes.

Comparison of Subject Device to the Primary Predicate Device

Attribute Multix Fusion Max Multix Fusion Comparison
(subject) Results
K142049 (primary
predicate)
Ceiling Semi-automated Semi-automated Same
mounted
support
(unchanged)
X-ray tube 80 kW 80 kW Same
assembly
(unchanged)
Two-focus Two-focus
Collimator Standard collimator(ACSS) Standard collimator(ACSS) Same
(unchanged)
Patient Radiographic table Radiographic table Charging tray
Table motorized with floating table motorized with floating
top (wireless detector) table top (wireless
detector)

Radiographic table Radiographic table Same

motorized with floating table motorized with floating
top (integrated detector) table top (integrated
detector)
Bucky Wall BWS for integrated detector BWS for integrated Same
Stand
motorized height adjustment detector motorized height
(vertical movement) adjustment (vertical
movement)
 BWS for wireless detector BWS for wireless detector Only motorized
motorized height adjustment motorized or manual height
(vertical movement) height adjustment (vertical adjustment
movement)

Touch Graphical user interface Graphical user interface Same

Interface
(unchanged)
X-ray 55kW, 65 kW or 80 kW 55kW, 65 kW or 80 kW Same
generator
(unchanged)
Integrated Pixium 4343RCE Pixium 4343RG Compared to
detector 43 cm x 43 cm
TRIXELL 43 cm x 43 cm the predicate
Pixium
Pixium 4343RC 4343RC-the
43 cm x 43 cm active area is
smaller but the
_ performance
(e.g. DQE,
MTF) is similar
Portable Pixium 3543EZh PaxScan 4336W Same
Wireless 43 cm x 35 cm 43cm x 36 cm
Detector technology with
(wi-D) WIFI feature
TRIXELL Pixium 2430EZ
30 cm x 24 cm
Operating RAD Single Exposure RAD Single Exposure Same
modes
(unchanged)
Imaging Fluorospot Compact PC Fluorospot Compact PC Same
System based, based,
(unchanged)
high res digital high res digital
Display 19” Black & White Black & White Same
(unchanged)
or Color or Color

DICOM 3 Send, StC, Print, Send, StC, Print, Same

Functions
(unchanged) Query/Retrieve, Get Query/Retrieve, Get

Worklist, MPPS Worklist, MPPS

Radiographi 92-line grid 80-line grid (ratio10:1) More lines,

c different ratio
Grid (ratio 13:1)
85-line grid 50-line grid (ratio10:1)
(ratio 5:1) (optional)

Accessory Remote Control Remote Control Same

(unchanged)
 console console

Fixed Subject Detector Compared to the Fixed Primary Predicate Detector

Technical Trixell Pixium Trixell Pixium Comparison
Specifications 4343RCE detector 4343RC detector Results
(fixed) (subject) (fixed) (predicate)
Dimensions 423.3 mm x 425.4 mm 424.6 mm x 425.5 mm Difference not
significant
Resolution 2860 x 2874 pixels 2869 x 2874 pixels Difference not
significant
Pixel size 148 μm 148 μm Same
Semiconductor Amorphous silicon, a- Amorphous silicon, a- Same
Material Si Si
Scintillator Cesium iodide (CsI) Cesium iodide (CsI) Same
_ Acquisition depth 16 bit 16 bit Same
DQE (Detective DQE @ 0.05 lp/mm (2 DQE @ 0.05 lp/mm (2 Difference not
Quantum μGy), 65%
Efficiency) μGy), 67% significant
MTF MTF @ 1 lp/mm, 62% MTF @ 1 lp/mm, 63% Difference not
(Modulations
significant
transfer function)

Wireless Subject Detector Compared to the Wireless Primary Predicate Detector

Technical Trixell Pixium 3543 Varian PaxScan Comparison
EZh detector 4336W detector
Specifications (wireless) Results
(wireless) (subject)
(predicate)
Dimensions 349 mm x 425 mm 356 mm x 427 mm Smaller
Resolution 2356 x 2872 pixels 3032 x 2520 pixels Difference not
significant
Pixel size 148 μm 139 μm Larger
Semiconductor Amorphous silicon, a- Amorphous silicon, a- Same
Material Si Si
Scintillator Cesium iodide (CsI) Cesium iodide (CsI) Same
Acquisition depth 16 bit 16 bit Same
DQE (Detective DQE @ 1 lp/mm (2 DQE @ 1 lp/mm (2 Difference not
Quantum μGy),
Efficiency) 50% μGy), 54% significant
MTF MTF @ 1 lp/mm, 61% MTF @ 1 lp/mm, 57% Difference not
(Modulations
transfer function) significant

Wireless Subject Detector Compared to the Wireless Reference Predicate Detector

Technical Trixell Pixium 3543 Trixell Pixium 3543 Comparison
Specifications EZh detector EZh detector Results
(wireless) (subject) (wireless)
(reference predicate)
Dimensions 349 mm x 425 mm 349 mm x 425 mm Same
 Resolution 2356 x 2872 pixels 2356 x 2872 pixels Same
Pixel size 148 μm 148 μm Same
Semiconductor Amorphous silicon, a- Amorphous silicon, a- Same
Material Si Si
Scintillator Cesium iodide (CsI) Cesium iodide (CsI) Same
Acquisition depth 16 bit 16 bit Same
DQE (Detective DQE @ 1 lp/mm (2 DQE @ 1 lp/mm (2 Same
Quantum μGy), 50% μGy), 50%
Efficiency)
MTF MTF @ 1 lp/mm, 61% MTF @ 1 lp/mm, 61% Same
(Modulations
transfer function)

Wireless Subject Detector Compared to the Wireless Primary Predicate Detector

Trixell Pixium Varian PaxScan
Technical 4336W detector Comparison
2430EZ detector (wireless)
Specifications Results
(wireless) (subject) (primary predicate)
_
Dimensions 228 mm x 284 mm 356 mm x 427 mm Smaller
Resolution 1560 x 1920 pixels 3032 x 2520 pixels Difference not
significant
Pixel size 148 μm 139 μm Larger
Semiconductor Amorphous silicon, a- Amorphous silicon, a-
Material Si Si Same
Scintillator Cesium iodide (CsI) Cesium iodide (CsI) Same
Acquisition depth 16 bit 16 bit Same
DQE (Detective DQE @ 1 lp/mm (2 DQE @ 1 lp/mm (2 Difference not
Quantum
Efficiency) μGy), 50% μGy), 54% significant
MTF Difference not
(Modulations MTF @ 1 lp/mm,61% MTF @ 1 lp/mm,57%
transfer function) significant

Wireless Subject Detector Compared to the Wireless Reference Predicate Detector

Trixell Pixium Trixell Pixium
Technical 2430EZ detector Comparison
2430EZ detector
Specifications (wireless) (reference Results
(wireless) (subject) predicate)
Dimensions 228 mm x 284 mm 228 mm x 284 mm Same
Resolution 1560 x 1920 pixels 1560 x 1920 pixels Same
Pixel size 148 μm 148 μm Same
Semiconductor Amorphous silicon, a- Amorphous silicon, a- Same
Material Si Si
Scintillator Cesium iodide (CsI) Cesium iodide (CsI) Same
Acquisition depth 16 bit 16 bit Same
DQE (Detective DQE @ 1 lp/mm (2 Same
DQE @ 1 lp/mm (2 μGy), 50%
Quantum
μGy), 50%
Efficiency)
MTF (Modulations MTF @ 1 lp/mm,61% Same
MTF @ 1 lp/mm,61%
transfer function)
 8. Summary of Technological Characteristics of the Subject Device as Compared with
the Predicate Device
The Multix Fusion Max is comparable in indications for use, design, material, functionality,
technology, energy source and is substantially equivalent to the commercially available
predicates. It uses the same or similar components cleared in the Multix Fusion (e.g.
tube, generator, ceiling-mounted tube support, table, Bucky wall stand and imaging
system) and the Ysio Max (wireless detectors).
The components of the subject device have many of the same technological
characteristics as the ones from the predicate devices. There are some technological
characteristics that differ slightly as shown in the comparison tables.
Testing and validation have been successfully completed and test results show that the subject
device Multix Fusion Max with all of its components are comparable to the predicate devices
and therefore is substantially equivalent to the predicate devices.
_ The modifications made to the subject device Multix Fusion Max do not affect the intended
use of the device nor do they alter its fundamental scientific technology from the 510(k)
cleared predicate devices.

9. Nonclinical Performance Testing

Non-clinical tests were conducted for the Multix Fusion Max during product development.
The modifications described in this Premarket Notification are supported with verification and
validation testing.
Multix Fusion Max conforms to the following standards: IEC 60601-1:2012, ed.3.1; IEC
60601-1-2 3rd 2007; IEC 60601-1-3:2008+A1:2013; IEC 62366: 2014; ISO 14971:2007; IEC
62304 Ed. 1.1 2015; IEC 60601-2-28 Edition 2.0 (2010); IEC 60601-2-54 Edition 1.1 2015;
PS 3.1 - 3.20 (2011); IEC 60601-1-6: 2013 and ISO 10993-1:2009.
Software Documentation for a Moderate Level of Concern software per FDA’s Guidance
Document “Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices” issued on May 11, 2005 is also included as part of this submission. The
performance data demonstrates continued conformance with special controls for medical
devices containing software. Non-clinical tests (integration and functional) were conducted on
the Multix Fusion Max during product development.
Detector integration testing consisted of functional and image quality tests. Functional tests
included exposure workflow, detector sharing function and image resend functions. Image
quality tests included flat field uniformity of the detector.
The Risk analysis was completed and risk control implemented to mitigate identified hazards.
The testing results support that all the software specifications have met the acceptance criteria.
Testing for verification and validation for the device was found acceptable to support the
claims of substantial equivalence.

10. General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will
enable the user to operate the device in a safe and effective manner. Several safety features
including visual and audible warnings are incorporated into the system design. In addition, the
 Multix Fusion Max Radiography X-ray system is continually monitored, and if an error occurs,
the system functions will be blocked and an error message will be displayed.
Risk management is ensured via a hazard analysis which is used to identify potential hazards.
These potential hazards are controlled via software development, verification and validation
testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to
recognized and established industry practice, and all equipment is subject to final performance
testing. Furthermore the operators are health care professionals familiar with and responsible
for the X-ray examinations to be performed.

11. Conclusion as to Substantial Equivalence

The Multix Fusion Max has the same indications for use as the predicate Multix Fusion. The
operating environment and mechanical design are similar. It is Siemens opinion, that the
Multix Fusion Max is substantially equivalent to the Multix Fusion, cleared 12/18/2014 in
K142049.
_ The predicate device was cleared based on non-clinical supportive information. Therefore, the
subject device non-clinical data supports the safety of software with verification and validation
testing. Verification and validation testing demonstrates that the Multix Fusion Max should
perform as intended. The non-clinical test data demonstrate that the Multix Fusion Max
device performance is comparable to the predicate device that is currently marketed for the
same intended use.
In summary, Siemens is of the opinion that the Multix Fusion Max does not introduce any new
potential safety risk and is substantially equivalent to and performs as well as the predicate
device.