Company ยท US
Carestream Health, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
53510(k) clearances (2 in 12 months)
92recalls (0 in 12 months)
82recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 62 |
| KPR | System, X-Ray, Stationary | 22 |
| IZL | System, X-Ray, Mobile | 20 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 17 |
| IWZ | Film, Radiographic | 6 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 |
| JAK | System, X-Ray, Tomography, Computed | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 |
| EIA | Unit, Operative Dental | 2 |
| LMC | Camera, Multi Format, Radiological | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 1 |
| NBL | Light-Induced Fluorescence Caries Detector | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 2026 | K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System Carestream Health | IZL |
| Jan 20, 2026 | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector Carestream Health | KPR |
| Sep 4, 2025 | K251168 | Image Suite Carestream Health, Inc. | LLZ |
| Dec 10, 2024 | K241505 | DRX-Revolution Mobile X-ray System Carestream Health, Inc. | IZL |
| Mar 12, 2024 | K233381 | DRX-Evolution Plus System Carestream Health, Inc. | KPR |
| Jan 20, 2023 | K223842 | DRX - Compass Carestream Health, Inc., CN | KPR |
| Mar 23, 2022 | K213568 | DRX-Rise Mobile X-ray System Carestream Health | IZL |
| Jan 14, 2022 | K213307 | Eclipse II with Smart Noise Cancellation Carestream Health, Inc. | MQB |
| Apr 2, 2021 | K202441 | Eclipse II with Smart Noise Cancellation Carestream Health, Inc. | MQB |
| Dec 2, 2020 | K203159 | Lux 35 Detector Carestream Health | MQB |
| Jun 26, 2020 | K201373 | DRX-Compass Carestream Health, Inc., CN | KPR |
| Feb 18, 2020 | K192894 | Vita Flex CR System with LLI Carestream Health, Inc. | MQB |
| Jan 22, 2020 | K193574 | Q-Rad System Carestream Health, Inc., CN | KPR |
| Dec 20, 2019 | K191879 | DRX-Evolution with Carestream Digital Tomosynthesis Carestream Health, Inc. | KPR |
| Nov 4, 2019 | K190330 | DRX-Evolution/Plus with Dual Energy Carestream Health, Inc. | KPR |
| May 17, 2019 | K191025 | DRX-Revolution Mobile X-ray System Carestream Health, Inc. | IZL |
| Feb 8, 2019 | K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors Carestream Health, Inc. | MQB |
| Jan 16, 2019 | K183474 | Carestream DRX-1 System with DRX Core Detectors Carestream Health, Inc. | MQB |
| Jun 21, 2018 | K180809 | Eclipse II Carestream Health, Inc. | MQB |
| Apr 13, 2018 | K180667 | SmartGrid Carestream Health, Inc. | MQB |
| Feb 5, 2018 | K173924 | DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. | IZL |
| Jan 19, 2018 | K173478 | OnSight 3D Extremity System Carestream Health, Inc. | JAK |
| Jun 21, 2017 | K170755 | DRX-Revolution Nano Mobile X-ray System Carestream Health, Inc. | IZL |
| Apr 11, 2017 | K170580 | Carestream Vue PACS Carestream Health, Inc. | LLZ |
| Mar 21, 2017 | K163157 | SmartGrid Carestream Health | MQB |
| Dec 13, 2016 | K163203 | Carestream DRX-Evolution Carestream Health, Inc. | KPR |
| Aug 30, 2016 | K160723 | OnSight 3D Extremity System Carestream Health, Inc. | JAK |
| Feb 12, 2016 | K153103 | CARESTREAM Vue PACS Carestream Health, Inc. | LLZ |
| Dec 9, 2015 | K152467 | Touch Ultrasound Carestream Health, Inc. | IYN |
| Nov 25, 2015 | K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors Carestream Health, Inc. | MQB |
| Sep 21, 2015 | K151774 | CARESTREAM Vue Motion Carestream Health, Inc. | LLZ |
| Jun 24, 2015 | K150766 | Carestream DRX-1 System Carestream Health, Inc. | MQB |
| May 8, 2015 | K150342 | Touch Ultrasound Carestream Health, Inc. | IYO |
| Mar 11, 2015 | K141837 | DRX-EVOLUTION Carestream Health, Inc. | KPR |
| Apr 1, 2014 | K140271 | TABLET VIEWER SOFTWARE FOR IMAGE SUITE Carestream Health, Inc. | LLZ |
| Mar 11, 2014 | K133442 | BONE SUPPRESSION SOFTWARE Carestream Health, Inc. | MQB |
| Feb 6, 2014 | K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION Carestream Health, Inc. | LLZ |
| Jun 11, 2013 | K130567 | DR LONG LENGTH IMAGING SOFTWARE Carestream Health, Inc. | MQB |
| Jun 7, 2013 | K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR Carestream Health, Inc. | MQB |
| Oct 23, 2012 | K122523 | CARESTREAM VUE PACS Carestream Health, Inc. | LLZ |
| Aug 28, 2012 | K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) Carestream Health, Inc. | MUE |
| Apr 13, 2012 | K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc. | IZL |
| Mar 2, 2012 | K111423 | CS 1600 INTRAORAL CAMERA Carestream Health, Inc. | NBL |
| Nov 10, 2011 | K112321 | CS 1200 Carestream Health, Inc. | EIA |
| Oct 20, 2011 | K110919 | CARESTREAM PACS Carestream Health, Inc. | LLZ |
| Oct 6, 2011 | K111566 | DRYVIEW CHROMA IMAGING SYSTEM Carestream Health, Inc. | LMC |
| Sep 23, 2011 | K111649 | CS 7600 Carestream Health, Inc. | MUH |
| Aug 18, 2009 | K091186 | KODAK 1500 INTRAORAL CAMERA Carestream Health, Inc. | EIA |
| Jul 20, 2009 | K091889 | DRX-EVOLUTION, MODEL VX3733-SYS Carestream Health, Inc. | KPR |
| May 22, 2009 | K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER Carestream Health, Inc. | LMC |
Newest 50 of 53.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2023 | Carestream Health, Inc. DRX Revolution Mobile X-Ray System Open, Classified |
IZL | K191025 |
| Nov 9, 2023 | Carestream Health, Inc. 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), im Open, Classified |
IZL | K191025 |
| Mar 2, 2023 | Carestream Health, Inc. 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 S Open, Classified |
KPR | K201373 |
| Jan 6, 2020 | Carestream Health, Inc. 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 Consol Terminated |
KPR | K060550 |
| Mar 19, 2019 | Carestream Health, Inc. 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 tomograp Terminated |
JAK | K173478 |
| Jun 19, 2017 | Carestream Health Inc DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution ---
The DRX-Revolution is a mobile sy Terminated |
IZL | K120062 |
| Jan 19, 2017 | Carestream Health Inc Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System
Diagnostic ultrasound imaging or fluid flow analysis of the human body Terminated |
IYN | K152467 |
| Jan 12, 2017 | Carestream Health Inc Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 146 Terminated |
IZL | K120062 |
| Jul 18, 2016 | Carestream Health Inc Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound
Diagnostic ultrasound imaging or fluid flow analysis of the hu Terminated |
IYN | K152467 |
| May 2, 2016 | Carestream Health Inc CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/ Terminated |
LLZ | K100094 |
| May 2, 2016 | Carestream Health Inc CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F Terminated |
LLZ | K100094 |
| Aug 22, 2015 | Carestream Health Inc CARESTREAM DRX-EVOLUTION X-Ray System
Product Usage:
The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature Terminated |
KPR | K141837 |
| Apr 3, 2015 | Carestream Health, Inc. CS 8100 3D, CATALOG # (s): 5311162, 5311188.
Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial Terminated |
MUH | K133406 |
| Apr 3, 2015 | Carestream Health, Inc. 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 Terminated |
MUH | K120975 |
| Dec 17, 2014 | Carestream Health, Inc. CARESTREAM DIRECTVIEW CR Software
Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Terminated |
LLZ | K020635 K923554 |
| Dec 16, 2014 | Carestream Health Inc DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc.
The DRX-Revolution Mobile X-Ray Syst Terminated |
IZL | K120062 |
| Aug 10, 2014 | Carestream Health, Inc. 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 t Terminated |
KPR | K051258 |
| Aug 1, 2014 | Carestream Health Inc. Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Terminated |
IWZ | None listed |
| Aug 1, 2014 | Carestream Health Inc. INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Terminated |
IWZ | None listed |
| Aug 1, 2014 | Carestream Health Inc. KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an Terminated |
KPR | None listed |
| Mar 4, 2014 | Carestream Health Inc. Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France --
--- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICAT Terminated |
EHD | K060292 |
| Mar 4, 2014 | Carestream Health Inc. Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/ Terminated |
EHD | K060292 |
| Jan 29, 2014 | Carestream Health Inc. Carestream DRX Evolution System (Standard Q)
The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical re Terminated |
KPR | None listed |
| Jan 27, 2014 | Carestream Health, Inc. KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. Terminated |
KPR | K051258 |
| Jan 21, 2014 | Carestream Health, Inc. DR 7500 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 collimat Terminated |
IZL | K051258 |
| Jan 21, 2014 | Carestream Health, Inc. DRX-Evolution with CSH 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 c Terminated |
IZL | K091889 |
| Jan 21, 2014 | Carestream Health, Inc. 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 co Terminated |
IZL | K091889 |
| Jan 3, 2014 | Carestream Health Inc. Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray sys Terminated |
IZL | None listed |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | None listed |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hos Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for ho Terminated |
LLZ | K110919 |
| Nov 13, 2013 | Carestream Health Inc. Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS
The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for Terminated |
LLZ | K110919 |
Newest 50 of 92.