January 20, 2023

Carestream Health, Inc.

℅ Jessica Deryke
Regulatory Affairs Manager
Building 7, No. 1510 Chuanqiao Road
China (Shanghai) Pilot Free Trade Zone
Shanghai, 201206
CHINA

Re: K223842
Trade/Device Name: DRX-Compass
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary x-ray system
Regulatory Class: Class II
Product Code: KPR
Dated: December 14, 2022
Received: December 22, 2022

Dear Jessica Deryke:

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# 04017.05.02
Silver Spring, MD 20993
www.fda.gov
K223842 - Jessica Deryke 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/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
2023.01.20
Lu Jiang 11:14:20
-05'00'
Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Imaging Devices and Electronic
Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
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: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K223842

Device Name
DRX-Compass

Indications for Use (Describe)

The device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.
The system can be used to perform radiographic imaging of various portions of the human body, including the skull,
spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography

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 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 “510(k) Summary” K223842

510(k) Owner Name: Carestream Health, Inc.

510(k) Owner Address: 150 Verona Street
Rochester, NY, 14608

510(k) Owner Phone: 585-627-6505

510(k) Owner Fax: 585-627-8802

Contact Person & Info: Jessica DeRyke

Regulatory Affairs Manager
[email protected]
585-489-7627

Date Summary Prepared: December 9, 2022

Predicate
510(k) Submitter: Carestream Health, Inc.
510(k) Number: K201373
Trade Name: DRX-Compass
Device: System, X-Ray, Stationary
Regulation Description: Stationary x-ray system
Review Panel: Radiology
Product Code: KPR
Regulation Number: 21 CFR 892.1680
Device Class: II

Modified
510(k) Submitter: Carestream Health, Inc.
Trade Name: DRX-Compass
Device: System, X-Ray, Stationary
Regulation Description: Stationary x-ray system
Review Panel: Radiology
Product Code: KPR
Regulation Number: 21 CFR 892.1680
Device Class: II
Device Description:
The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic
images of various portions of the human body. The system consists of a combination of
components including various models of high voltage x-ray generators, control panels or
workstation computers, various models of patient support tables, wall-mounted image
receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and
collimator (beam-limiting device).

Page 1 of 5
The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR)
receptors.
Smart Features are added to the DRX-Compass system to provide remote capabilities for existing
functions of the DRX-Compass system. These remote capabilities simplify exam set up and
improve workflow for the operator while preparing for the patient exposure. The “smart features”,
described below, are designed to reduce the technologist's manual tasks and to speed up workflow
for existing features of the system. These improvements are referred to as “smart features” in the
product documentation. Implementation of these “smart features” does not change the intended use
of the system.
• Real-time Video Assistance:
The modified DRX-Compass System uses the real-time video output of the visual auxiliary
components (cameras) to display the patient on the user interface to assist the operator in
guiding the patient to adjust the position and posture, and assisting adjustment X-ray field,
X-ray gantry position, etc.
• Long Length Imaging (LLI):
The modified DRX-Compass System provides the capability for the operator to select LLI
parameters on the user interface without needing to physically be in the exam room. An
LLI exam consists of two to five images stitched together to create one larger image of a
leg or spine which is too long to show in a single image capture. The operator selects the
top and bottom of the desired region of interest, and the system determines the number of
images needed for the exam.
• Collimation:
The modified DRX-Compass System allows the operator to collimate the intended location
of the x-ray beam remotely from the user interface. Previously, the operator would have to
physically go into the exam room and manually use collimator knobs to adjust the location
of the light that represents the x-ray beam for purposes of exam set up.
• Patient Picture:
The modified DRX-Compass System can now use camera to take a picture of patient to be
delivered with the x-ray image. The patient picture interface supports the capture of a
picture of the patient’s physical anatomy from the live camera view automatically while
system is taking the exposure. The operator can add these pictures to the patient record,
making the pictures available for viewing along with the acquired x-ray images.

Page 2 of 5
Indication for Use / Intended Use:
The device is indicated for use in obtaining diagnostic quality radiographic images to aid the
physician with diagnosis. The system can be used to perform radiographic imaging of various
portions of the human body, including the skull, spinal column, extremities, chest, abdomen, and
other body parts. The device is not indicated for use in mammography.
Substantial Equivalence:
Based upon information provided within this submission, we believe that the modified DRX-
Compass, is substantially equivalent to the legally marketed DRX-Compass System (predicate
device).
In accordance with FDA Final Guidance “The 510(k) Program: Evaluating Substantial Equivalence
in Premarket Notifications [510(k)]” issued July 28, 2014, the critical decision points outlined in
the proposed 510(k) Decision-Making Flowchart in Appendix A have been considered. The
proposed predicate device, DRX-Compass System, has been found substantially equivalent by FDA
through the 510(k) process and is legally marketed. The Indications for Use for the modified device
are identical to the predicate indications for use.
According to 14971, Risk Management methodology, no new risks have been identified that raise
additional questions of safety and performance. All product risks have been mitigated as far as
possible and there have been no changes to risk control measures in the current product risk
analysis. Testing to recognized FDA consensus standards and internal bench testing have indicated
substantial equivalence.
Comparison of Technological Characteristics

A comparison chart (Figure 1) provides the similarities and differences between the modified and
predicate devices.

Page 3 of 5
 Figure 1: Comparison Chart

Predicate
Modified
Feature DRX-Compass System
DRX-Compass System
(K201373)

Digital Radiography Imaging Carestream DRX Plus Detectors Supports the same detectors as
Devices (Detector) (K150766) the predicate devices and the
Focus 35C Detector (K192512) additional detectors listed
Focus 43C Detector (K200622) below:

DRX Plus 2530 (K183245)

Focus HD 35 (K213646)
Focus HD 43 (K213529)
Lux 35 (K203159)
Application System Software Image View Software Same

Wall Stand Non-Tilting: WS-NT Same

Tilting options: WS-T
Radiographic Table Floating Top, non-Elevating Same
QT-740
Floating Top, Elevating: QT-
750

X-Ray Generator Options Three Phase, CGF-50-2, CGF- Same

50-3, CGF-65-3, and CGF-80-3
X-Ray Tube Toshiba (Canon):E7254FX, Same
E7252X
X-Ray Collimator Manual: Ralco R221/A DHHS Same
Automated: Ralco R221. ACS
DHHS
Electrical Safety IEC 60601-1 Same
IEC 60601-1-2
IEC 60601-2-54

Page 4 of 5
Summary of Non-Clinical Performance Testing and Data:
Non-clinical testing such as standards testing are the same as that of the predicate. The
verification and validation testing of the modified device demonstrates that the modified
device performs as well as the predicate and is substantially equivalent. Predefined acceptance
criteria were met and demonstrated that the device is as safe, as effective, and performs as well as
or better than the predicate device.

The flat panel detector DQE/MTF data shows that the additional detectors supported by the
modified device (DRX-Compass) are equivalent in image quality to that of the DRX Plus detectors
cleared with the predicate.

DRX-Compass complies with and/or was tested in accordance with the following FDA and
International Standards:

• AAMI ES60601-1:2005 +C1:A2: 2012 Medical electrical equipment - Part 1:

General requirements for basic safety and essential performance (IEC 60601-1:2005
(Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012) (FDA Consensus
Standards number 19-4)
• IEC 60601-1-6: 2010 + A1: 2013, Edition 3.1 - Medical electrical equipment – Part
1-6: General requirements for basic safety and essential performance – Collateral
standard: Usability (FDA Consensus Standards number 5-89
• IEC 60601-1-3:2008 (Second Edition) + A1:2013 Medical electrical equipment -
Part 1-3: General requirements for basic safety and essential performance -
Collateral Standard: Radiation protection in diagnostic X-ray equipment (FDA
Consensus Standards number 12-269)
• IEC 60601-2-54:2009, AMD1:2015 Medical electrical equipment - Part 2-54:
Particular requirements for the basic safety and essential performance of X-ray
equipment for radiography and radioscopy (FDA Consensus Standards number 12-
317)
• IEC 62366: 2007 + A1: 2014, Edition 1.0 - Medical devices – Application of
usability engineering to medical devices (FDA Consensus Standards number 5-114)
• ISO 14971:2019 Medical devices - Applications of risk management to medical
devices (FDA Consensus Standards number 5-125)

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