Carestream Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Image Suite, DRX-Revolution Mobile X-ray System, DRX-Evolution Plus System
48
Total
48
Cleared
0
Denied
FDA 510(k) Regulatory Record - Carestream Health, Inc. Radiology ✕
45 devices
Cleared
Sep 04, 2025
Image Suite
Radiology
142d
Cleared
Dec 10, 2024
DRX-Revolution Mobile X-ray System
Radiology
196d
Cleared
Mar 12, 2024
DRX-Evolution Plus System
Radiology
162d
Cleared
Jan 20, 2023
DRX - Compass
Radiology
29d
Cleared
Jan 14, 2022
Eclipse II with Smart Noise Cancellation
Radiology
102d
Cleared
Apr 02, 2021
Eclipse II with Smart Noise Cancellation
Radiology
219d
Cleared
Jun 26, 2020
DRX-Compass
Radiology
31d
Cleared
Feb 18, 2020
Vita Flex CR System with LLI
Radiology
130d
Cleared
Jan 22, 2020
Q-Rad System
Radiology
30d
Cleared
Dec 20, 2019
DRX-Evolution with Carestream Digital Tomosynthesis
Radiology
158d
Cleared
Nov 04, 2019
DRX-Evolution/Plus with Dual Energy
Radiology
263d
Cleared
May 17, 2019
DRX-Revolution Mobile X-ray System
Radiology
29d
Looking for a specific device from Carestream Health, Inc.? Search by device name or K-number.
Search all Carestream Health, Inc. devices