Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

49 results for "Carestream Health, Inc."
1–24 of 49
Search insights Median review: 92d Cleared: 100% Top manufacturer: Carestream Health, Inc. Lead specialty: Radiology
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Dec 10, 2024
DRX-Revolution Mobile X-ray System
K241505 · IZL
Carestream Health, Inc.
Radiology · 196d
Cleared Mar 12, 2024
DRX-Evolution Plus System
K233381 · KPR
Carestream Health, Inc.
Radiology · 162d
Cleared Jan 20, 2023
DRX - Compass
K223842 · KPR
Carestream Health, Inc.
Radiology · 29d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307 · MQB
Carestream Health, Inc.
Radiology · 102d
Cleared Apr 02, 2021
Eclipse II with Smart Noise Cancellation
K202441 · MQB
Carestream Health, Inc.
Radiology · 219d
Cleared Jun 26, 2020
DRX-Compass
K201373 · KPR
Carestream Health, Inc.
Radiology · 31d
Cleared Feb 18, 2020
Vita Flex CR System with LLI
K192894 · MQB
Carestream Health, Inc.
Radiology · 130d
Cleared Jan 22, 2020
Q-Rad System
K193574 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Dec 20, 2019
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · KPR
Carestream Health, Inc.
Radiology · 158d
Cleared Nov 04, 2019
DRX-Evolution/Plus with Dual Energy
K190330 · KPR
Carestream Health, Inc.
Radiology · 263d
Cleared May 17, 2019
DRX-Revolution Mobile X-ray System
K191025 · IZL
Carestream Health, Inc.
Radiology · 29d
Cleared Feb 08, 2019
Carestream DRX-1 System with DRX Plus 2530 Detectors
K183245 · MQB
Carestream Health, Inc.
Radiology · 79d
Cleared Jan 16, 2019
Carestream DRX-1 System with DRX Core Detectors
K183474 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Jun 21, 2018
Eclipse II
K180809 · MQB
Carestream Health, Inc.
Radiology · 85d
Cleared Apr 13, 2018
SmartGrid
K180667 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Feb 05, 2018
DRX-Revolution Nano Mobile X-ray System
K173924 · IZL
Carestream Health, Inc.
Radiology · 41d
Cleared Jan 19, 2018
OnSight 3D Extremity System
K173478 · JAK
Carestream Health, Inc.
Radiology · 67d
Cleared Jun 21, 2017
DRX-Revolution Nano Mobile X-ray System
K170755 · IZL
Carestream Health, Inc.
Radiology · 100d
Cleared CT Apr 11, 2017
Carestream Vue PACS
K170580 · LLZ
Carestream Health, Inc.
Radiology · 42d
Cleared Dec 13, 2016
Carestream DRX-Evolution
K163203 · KPR
Carestream Health, Inc.
Radiology · 28d
Cleared CT Aug 30, 2016
OnSight 3D Extremity System
K160723 · JAK
Carestream Health, Inc.
Radiology · 167d
Cleared Feb 12, 2016
CARESTREAM Vue PACS
K153103 · LLZ
Carestream Health, Inc.
Radiology · 109d
Cleared Dec 09, 2015
Touch Ultrasound
K152467 · IYN
Carestream Health, Inc.
Radiology · 100d