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Carestream Health, Inc., Global R&D Center: FDA-registered device maker in Shanghai, China, 4 510(k) clearances

Name: Carestream Health, Inc., Global R&D Center FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carestream Health, Inc., Global R&D Center is registered with the FDA (registration 3005778458) in Shanghai, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 20, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3005778458
Address: Bldg 15 No. 27 Xin Jinqiao Road, Shanghai, China, 201206
Owner or operator: Carestream Health, Inc. (9097221)
Roles: Specification developer
First device listed: January 15, 2010
Registered through: 2026
Brand names listed: CARESTREAM DR LONG LENGTH IMAGING STAND, CARESTREAM DRX-EVOLUTION PLUS, Carestream Image Suite, DR-FIT X-ray System, DRX-Ascend System, DRX-Compass X-ray System, Focus 35C Detector, Lux HD 35 Detector and more

Devices it lists

Device	Product code	Class	Role	Source
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Specification developer	accessdata.fda.gov
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Specification developer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Specification developer	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Specification developer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Specification developer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 20, 2026	K250954	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector	KPR	Substantially Equivalent	Carestream Health	accessdata.fda.gov
October 16, 2019	K192512	Focus 35C Detector, Trimax 35C Detector	MQB	Substantially Equivalent	Iray Technology Taicang , Ltd.	accessdata.fda.gov
March 11, 2010	K100094	CARESTREAM IMAGE SUITE	LLZ	Substantially Equivalent	Carestream Heatlh, Inc.	accessdata.fda.gov
June 20, 2001	K011486	Q-RAD RADIOGRAPHIC SYSTEM	KPR	Substantially Equivalent	Quantum Medical Imaging, LLC	accessdata.fda.gov

Compare with other makers

Updated January 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.