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."
25–48 of 49
Search insights Median review: 92d Cleared: 100% Top manufacturer: Carestream Health, Inc. Lead specialty: Radiology
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142 · MQB
Carestream Health, Inc.
Radiology · 26d
Cleared Sep 21, 2015
CARESTREAM Vue Motion
K151774 · LLZ
Carestream Health, Inc.
Radiology · 82d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766 · MQB
Carestream Health, Inc.
Radiology · 92d
Cleared May 08, 2015
Touch Ultrasound
K150342 · IYO
Carestream Health, Inc.
Radiology · 86d
Cleared Mar 11, 2015
DRX-EVOLUTION
K141837 · KPR
Carestream Health, Inc.
Radiology · 247d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Carestream Health, Inc.
Radiology · 57d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Carestream Health, Inc.
Radiology · 119d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Carestream Health, Inc.
Radiology · 150d
Cleared CT Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Carestream Health, Inc.
Radiology · 105d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Carestream Health, Inc.
Radiology · 214d
Cleared Apr 13, 2012
DRX-REVOLUTION MOBILE X-RAY SYSTEM
K120062 · IZL
Carestream Health, Inc.
Radiology · 95d
Cleared Mar 02, 2012
CS 1600 INTRAORAL CAMERA
K111423 · NBL
Carestream Health, Inc.
Dental · 284d
Cleared Nov 10, 2011
CS 1200
K112321 · EIA
Carestream Health, Inc.
Dental · 90d
Cleared Oct 20, 2011
CARESTREAM PACS
K110919 · LLZ
Carestream Health, Inc.
Radiology · 202d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Carestream Health, Inc.
Radiology · 122d
Cleared Sep 23, 2011
CS 7600
K111649 · MUH
Carestream Health, Inc.
Radiology · 102d
Cleared Aug 18, 2009
KODAK 1500 INTRAORAL CAMERA
K091186 · EIA
Carestream Health, Inc.
Dental · 117d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · KPR
Carestream Health, Inc.
Radiology · 26d
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Carestream Health, Inc.
Radiology · 88d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Carestream Health, Inc.
Radiology · 19d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · KPR
Carestream Health, Inc.
Radiology · 30d