Data / Medical devices / United States / Carestream Health, Inc
Carestream Health, Inc: FDA-registered device maker in Rochester, NY, United States, 18 510(k) clearances and 1 PMA approval
Carestream Health, Inc is registered with the FDA (registration 1317307) in Rochester, NY, United States. It lists 13 device types. The FDA files 18 510(k) clearances and 1 PMA approval under its listings, the newest dated March 11, 2026. 13 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1317307
- Address
- 1049 West Ridge Road, Rochester, NY, United States, 14615
- Owner or operator
- Carestream Health, Inc. (9097221)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 20, 1997
- Registered through
- 2026
- Brand names listed
- AERMEI AMV Laser Imaging Film 125SH 20X25CM (8X10IN) AMV, AERMEI AMV Laser Imaging Film 125SH 25X30CM (10X12IN) AMV, AERMEI AMV Laser Imaging Film 125SH 28X35CM (11X14IN) AMV, AERMEI AMV Laser Imaging Film 125SH 35X43CM (14X17IN) AMV, CARESTREAM CR Mammography Cassette with EHR-M3 Screen, CARESTREAM DRX-1 System, CARESTREAM DRX-EVOLUTION PLUS, CARESTREAM DRX-MOBILE RETROFIT KIT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cassette, Radiographic Film | IXA | 2 | Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Film, Radiographic | IWZ | 1 | Specification developer | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Manufacturer | accessdata.fda.gov |
| Grid, Radiographic | IXJ | 1 | Manufacturer | accessdata.fda.gov |
| Screen, Intensifying, Radiographic | EAM | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stool, Operating-Room | FZM | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 11, 2026 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | IZL | Substantially Equivalent | Carestream Health | accessdata.fda.gov |
| 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 9, 2025 | K252911 | Lux HD 2530 detector (Lux HD 2530) | MQB | Substantially Equivalent | Iray Imaging Technology (Haining) Limited | accessdata.fda.gov |
| March 18, 2025 | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | MQB | Substantially Equivalent | Iray Imaging Technology (Haining) Limited | accessdata.fda.gov |
| March 29, 2022 | K213646 | Focus HD 35 Detector | MQB | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| March 29, 2022 | K213529 | Focus HD 43 Detector | MQB | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| April 1, 2020 | K200622 | Focus 43C detector, TRIMAX 43C detector | MQB | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| October 16, 2019 | K192512 | Focus 35C Detector, Trimax 35C Detector | MQB | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
| February 5, 2018 | K173924 | DRX-Revolution Nano Mobile X-ray System | IZL | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| August 30, 2016 | K160723 | OnSight 3D Extremity System | JAK | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| November 25, 2015 | K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | MQB | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| June 24, 2015 | K150766 | Carestream DRX-1 System | MQB | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| June 7, 2013 | K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR | MQB | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| March 11, 2010 | K100094 | CARESTREAM IMAGE SUITE | LLZ | Substantially Equivalent | Carestream Heatlh, Inc. | accessdata.fda.gov |
| April 6, 2009 | K090318 | CARESTREAM DRX-1 SYSTEM | MQB | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| May 24, 2004 | K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | IXA | Substantially Equivalent | Eastman Kodak Company | accessdata.fda.gov |
| July 2, 2002 | K021829 | MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM | MQB | Substantially Equivalent | Eastman Kodak Company | accessdata.fda.gov |
| November 22, 1994 | K945039 | MCI OPTONIX CASSETTE OKAMOTO CASSETE | IXA | Substantially Equivalent | Mci Optonix, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 3, 2010 | P080018 | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | MUE | 1 | December 1, 2010 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 2, 2023 | 93253 | Class II | Ongoing | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and so | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and sm | accessdata.fda.gov |
| October 2, 2023 | 93241 | Class II | Ongoing | DRX Revolution Mobile X-Ray System | Unexpected failure of electrical components within the CPI generator. | accessdata.fda.gov |
| January 30, 2023 | 91698 | Class II | Ongoing | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P C | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury | accessdata.fda.gov |
| January 6, 2020 | 84616 | Class II | Terminated | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interf | Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. | accessdata.fda.gov |
| March 19, 2019 | 82491 | Class II | Terminated | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-r | When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam. | accessdata.fda.gov |
| January 8, 2015 | 70649 | Class II | Terminated | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo | Units device head descended unexpectedly | accessdata.fda.gov |
| October 30, 2014 | 69703 | Class II | Terminated | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. | Reduced mammographic image quality when attempting to print true size multi-format images | accessdata.fda.gov |
| July 9, 2014 | 68727 | Class II | Terminated | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube a | An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from th | accessdata.fda.gov |
| December 26, 2013 | 67188 | Class II | Terminated | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. | accessdata.fda.gov |
| November 25, 2013 | 67047 | Class II | Terminated | DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationa | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | accessdata.fda.gov |
| June 12, 2012 | 62310 | Class II | Terminated | Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone a | Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns. | accessdata.fda.gov |
| March 6, 2007 | 38248 | Not yet classified | Terminated | Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s,. | The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR). | accessdata.fda.gov |
| March 6, 2007 | 38233 | Not yet classified | Terminated | Kodak Direct View DR7500 System, Catalog #s,, --- A stationary X-Ray System. Device Listing # E222512. | The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR). | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Screen, Intensifying, Radiographic
- All makers of Cassette, Radiographic Film
- All makers of System, X-Ray, Mobile
- All makers of System, X-Ray, Stationary
- All makers of Full Field Digital, System, X-Ray, Mammographic
Updated March 11, 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.