Medical Device Manufacturer · US , Rochester , NY

Carestream Health - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2017

Recent clearances: Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System, DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector, DRX-Rise Mobile X-ray System

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5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Carestream Health Radiology ✕

5 devices

1-5 of 5

Cleared Mar 11, 2026

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

Radiology · 166d

Cleared Jan 20, 2026

DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35...

Radiology · 298d

Cleared Mar 23, 2022

DRX-Rise Mobile X-ray System

Radiology · 134d

Cleared Dec 02, 2020

Lux 35 Detector

Radiology · 40d

Cleared Mar 21, 2017

Radiology · 131d