Medical Device Manufacturer · US , Rochester , NY

Carestream Health, Inc. - FDA 510(k) Cleared Devices

48 submissions · 48 cleared · Since 2008
48
Total
48
Cleared
0
Denied
45 devices
26-45 of 45
Cleared Sep 21, 2015
CARESTREAM Vue Motion
K151774 · LLZ
Radiology · 82d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766 · MQB
Radiology · 92d
Cleared May 08, 2015
Touch Ultrasound
K150342 · IYO
Radiology · 86d
Cleared Mar 11, 2015
DRX-EVOLUTION
K141837 · KPR
Radiology · 247d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Radiology · 57d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Radiology · 119d
Cleared Feb 06, 2014
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
K132824 · LLZ
Radiology · 150d
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567 · MQB
Radiology · 99d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464 · MQB
Radiology · 105d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Radiology · 64d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Radiology · 214d
Cleared Apr 13, 2012
DRX-REVOLUTION MOBILE X-RAY SYSTEM
K120062 · IZL
Radiology · 95d
Cleared Oct 20, 2011
CARESTREAM PACS
K110919 · LLZ
Radiology · 202d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Radiology · 122d
Cleared Sep 23, 2011
CS 7600
K111649 · MUH
Radiology · 102d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · KPR
Radiology · 26d
Cleared May 22, 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · LMC
Radiology · 88d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Radiology · 56d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Radiology · 19d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · KPR
Radiology · 30d
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