Medical Device Manufacturer · US , Rochester , NY

Carestream Health, Inc.

48 submissions · 48 cleared · Since 2008
48
Total
48
Cleared
0
Denied

Carestream Health, Inc. has 48 FDA 510(k) cleared radiology devices. Based in Rochester, US.

Latest FDA clearance: Sep 2025. Active since 2008.

Browse the FDA 510(k) cleared devices submitted by Carestream Health, Inc.Filter by specialty or product code using the sidebar.

48 devices
1–12 of 48
Image Suite
K251168 · LLZ System, Image Processing, Radiological · Radiology
Sep 2025 142d
DRX-Revolution Mobile X-ray System
K241505 · IZL System, X-ray, Mobile · Radiology
Dec 2024 196d
DRX-Evolution Plus System
K233381 · KPR System, X-ray, Stationary · Radiology
Mar 2024 162d
DRX - Compass
K223842 · KPR System, X-ray, Stationary · Radiology
Jan 2023 29d
Eclipse II with Smart Noise Cancellation
K213307 · MQB Solid State X-ray Imager (flat Panel/digital Imager) · Radiology
Jan 2022 102d
Eclipse II with Smart Noise Cancellation
K202441 · MQB Solid State X-ray Imager (flat Panel/digital Imager) · Radiology
Apr 2021 219d
DRX-Compass
K201373 · KPR System, X-ray, Stationary · Radiology
Jun 2020 31d
Vita Flex CR System with LLI
K192894 · MQB Solid State X-ray Imager (flat Panel/digital Imager) · Radiology
Feb 2020 130d
Q-Rad System
K193574 · KPR System, X-ray, Stationary · Radiology
Jan 2020 30d
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · KPR System, X-ray, Stationary · Radiology
Dec 2019 158d
DRX-Evolution/Plus with Dual Energy
K190330 · KPR System, X-ray, Stationary · Radiology
Nov 2019 263d
DRX-Revolution Mobile X-ray System
K191025 · IZL System, X-ray, Mobile · Radiology
May 2019 29d

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