# Carestream Health, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 55 (2004–2026): 53 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Carestream Health, Inc. (50); Carestream Health (5)
- Product codes: MQB (15), KPR (11), LLZ (9), IZL (7), EIA (2), JAK (2), LMC (2), MUE (2), MYN (1), IYO (1), IYN (1), MUH (1)
- 510(k) review time since 2016: median 101 days, against 48 for FDA's reviews in the same codes and years (9 of 28 faster)
- Predicates its devices cite: 66 (33 its own); citations of its devices by later devices: 51 (33 its own)
- Recalls linked to its devices: 71 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eastman Kodak Company: 7 (https://510kreport.com/company/eastman-kodak)
- Olea Medical: 3 (https://510kreport.com/company/olea-medical)
- B-K Medical Aps: 2 (https://510kreport.com/company/b-k-medical)
- Cedara Software Corp.: 1 (https://510kreport.com/company/cedara-software)
- Orex Computed Radiography, Ltd.: 1 (https://510kreport.com/company/orex-computed-radiography)
- Carestream Heatlh, Inc.: 1 (https://510kreport.com/company/carestream-heatlh)
- Mirada Solutions, Ltd.: 1 (https://510kreport.com/company/mirada-solutions)
- Iray Imaging Technology (Haining) Limited: 1 (https://510kreport.com/company/iray-imaging-technology-haining)

## Firms that cite its devices most
- DRTECH Corporation: 2 (https://510kreport.com/company/drtech)
- Samsung Electronics Co., Ltd.: 1 (https://510kreport.com/company/samsung-electronics)
- Micro-X, Ltd.: 1 (https://510kreport.com/company/micro-x)
- Hinacom Software and Technology, Ltd.: 1 (https://510kreport.com/company/hinacom-software-and-technology)
- Shanghai United Imaging Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shanghai-united-imaging-healthcare)
- Agfa Healthcare N.V.: 1 (https://510kreport.com/company/agfa-healthcare)
- Solutions For Tomorrow AB: 1 (https://510kreport.com/company/solutions-for-tomorrow)
- Riverain Technologies, Inc.: 1 (https://510kreport.com/company/riverain-technologies)

## Its most-cited devices
- K120062: DRX-Revolution Mobile X-Ray System (2012), cited by 5
- K150766: Carestream DRX-1 System (2015), cited by 5
- K090318: Carestream DRX-1 System (2009), cited by 4
- K141837: DRX-Evolution (2015), cited by 3
- K191025: DRX-Revolution Mobile X-ray System (2019), cited by 3
- K083673: Carestream Pacs, Model Carestream Pacs Vii (2008), cited by 2

## Recent decisions
- K253185: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (Mar 11, 2026)
- K250954: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (Jan 20, 2026)
- K251168: Image Suite (Sep 4, 2025)
- K241505: DRX-Revolution Mobile X-ray System (Dec 10, 2024)
- K233381: DRX-Evolution Plus System (Mar 12, 2024)
- K223842: DRX - Compass (Jan 20, 2023)
- K213568: DRX-Rise Mobile X-ray System (Mar 23, 2022)
- K213307: Eclipse II with Smart Noise Cancellation (Jan 14, 2022)

Source page: https://510kreport.com/company/carestream-health