CARESTREAM HEALTH, INC., GLOBAL R&D CENTER

FDA Device Registration & Listing · SHANGHAI, CN · Registration 3005778458

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005778458
FEI Number
3005778458
Entity Name
CARESTREAM HEALTH, INC., GLOBAL R&D CENTER
City/State/Country
SHANGHAI, CN
Establishment Address
Bldg 15, No. 27 Xin Jinqiao Road, SHANGHAI 201206, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Carestream Health, Inc. (Owner Number: 9097221)
Owner / Operator Contact Address
150 Verona Street, Rochester, NY 14608, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Carestream Image Suite QT-740 QT-750 DRX-Ascend System Focus 35C Detector TRIMAX 35C Detector SPT2 RADIOGRAPHIC TABLE CARESTREAM DR LONG LENGTH IMAGING STAND Lux HD 43 Detector CARESTREAM DRX-EVOLUTION PLUS DRX-Compass X-ray System Lux HD 35 Detector DR-FIT X-ray System QS-500 X-RAY GENERATOR SYSTEM (REF: QG-50-2, QG-50, QG-50-SE, QG-65, QG-80) X-RAY GENERATOR SYSTEM (REF: QG-40, QG-40-2, QG-40-3, QG-40-SE) QW-420 QR-LCH,QT-LCH,QT-LCH-P,QT-TCH

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2011-03-08
IZZ Table, Radiographic, Non-Tilting, Powered Radiology Class 2 892.1980 2011-03-07
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2011-03-08
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-01-10
KXJ Table, Radiologic Radiology Class 2 892.1980 2010-01-15
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-03-13
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2026-03-13
IYB Tube Mount, X-Ray, Diagnostic Radiology Class 1 892.1770 2011-03-09
IZO Generator, High-Voltage, X-Ray, Diagnostic Radiology Class 1 892.1700 2011-03-09
IXY Holder, Radiographic Cassette, Wall-Mounted Radiology Class 1 892.1880 2011-03-09

Official Correspondent

Alyssa Haig

US Agent Details

Alyssa Haig Business: CARESTREAM HEALTH, INC. Email: alyssa.haig@carestream.com Phone: (610) 8066895

Related Public Records

Same Entity

Carestream Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1317267 Carestream Health, Inc. Rochester, NY, US
3029911 Carestream Health, Inc. WHITE CITY, OR, US
3015532525 CARESTREAM HEALTH, INC. Rochester, NY, US
3003578745 Rayco (Xiamen) Medical Products Company Limited XIAMEN Fujian, CN
1317307 Carestream Health, Inc Rochester, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005778458. Last updated year: 2026. Please use registration number 3005778458 when referencing this establishment in official correspondence.
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