Carestream Health, Inc

FDA Device Registration & Listing · Rochester, NY, US · Registration 1317307

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
1317307
FEI Number
1317307
Entity Name
Carestream Health, Inc
City/State/Country
Rochester, NY, US
Establishment Address
1049 West Ridge Road, Rochester, NY 14615, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Carestream Health, Inc. (Owner Number: 9097221)
Owner / Operator Contact Address
150 Verona Street, Rochester, NY 14608, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K192512
PMA Number
N/A

All Registered Proprietary Names

OnSight 3D Extremity System CR Cassettes for Vita Systems Carestream CR Cassettes Patient Chair T-MAT G/RA X-OMAT 2 Dental Duplicating DRYVIEW DVB+ Laser Imaging Film DRYVIEW DVM+ Mammography Laser Imaging Film Ultra-speed DRYVIEW DVB+ Premium Laser Imaging Film DRYVIEW DVE Laser Imaging Film INSIGHT AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV GBX Fixer and Replenisher GBX Developer and Replenisher AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV Rapid Access Twin Pack READYPRO Twin Pack TRIMAX TXM Laser Imaging Film DRYVIEW DVM Mammography Laser Imaging Film SD-SM Step Box Foot and Ankle Step Focus HD 43 Detector Lux HD 2530 Detector (Lux HD 2530) DRX-Revolution Mobile X-ray System Lux HD 35 Detector (Lux HD 35) Lux HD 43 Detector (Lux HD 43) DRX-LC Detector CARESTREAM DRX-1 System CARESTREAM DRX-MOBILE RETROFIT KIT CARESTREAM DRX-TRANSPORTABLE SYSTEM CARESTREAM DRX-TRANSPORTABLE SYSTEM/FLEX DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen DIRECTVIEW CR Mammography Feature CARESTREAM CR Mammography Cassette with EHR-M3 Screen Lux HD 43 Detector CARESTREAM DRX-EVOLUTION PLUS DRX-Compass X-ray System Lux HD 35 Detector DR-FIT X-ray System DRX Plus 2530C Detector Lux HD 35 Detector (Lux HD 35) Lux HD 43 Detector (Lux HD 43) Focus HD 35 Detector DRX-Revolution Nano Mobile X-ray System DRX Plus 3543 Detector DRX Plus 3543C Detector DRX Core 3543 Detector DRX Core 3543C Detector TRIMAX 3543C Detector TRIMAX 3543 Detector LUX 35 Detector Focus 35C Detector TRIMAX 35C Detector

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2016-09-20
IXA Cassette, Radiographic Film Radiology Class 2 892.1850 2009-02-07
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2011-03-09
IWZ Film, Radiographic Radiology Class 1 892.1840 2006-06-01
FZM Stool, Operating-Room General, Plastic Surgery Class 1 878.4950 2017-01-11
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-05-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-03-13
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2026-03-13
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-03-13
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2011-03-03
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2010-12-07
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
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2013-06-13
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-05-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-05-06
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2018-02-06
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2015-07-02
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-01-10

Official Correspondent

Alyssa Haig

US Agent Details

No US Agent registered (Local establishment).

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
3005778458 CARESTREAM HEALTH, INC., GLOBAL R&D CENTER SHANGHAI, CN
3015532525 CARESTREAM HEALTH, INC. Rochester, NY, US
3003578745 Rayco (Xiamen) Medical Products Company Limited XIAMEN Fujian, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1317307. Last updated year: 2026. Please use registration number 1317307 when referencing this establishment in official correspondence.
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