FDA 510(k) Applications Submitted by CARESTREAM HEALTH, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140271 |
02/03/2014 |
TABLET VIEWER SOFTWARE FOR IMAGE SUITE |
CARESTREAM HEALTH, INC. |
| K122523 |
08/20/2012 |
CARESTREAM VUE PACS |
CARESTREAM HEALTH, INC. |
| K120062 |
01/09/2012 |
DRX-REVOLUTION MOBILE X-RAY SYSTEM |
CARESTREAM HEALTH, INC. |
| K190330 |
02/14/2019 |
DRX-Evolution/Plus with Dual Energy |
Carestream Health, Inc. |
| K130567 |
03/04/2013 |
DR LONG LENGTH IMAGING SOFTWARE |
CARESTREAM HEALTH, INC. |
| K160723 |
03/16/2016 |
OnSight 3D Extremity System |
CARESTREAM HEALTH, INC. |
| K091889 |
06/24/2009 |
DRX-EVOLUTION, MODEL VX3733-SYS |
CARESTREAM HEALTH, INC. |
| K133442 |
11/12/2013 |
BONE SUPPRESSION SOFTWARE |
CARESTREAM HEALTH, INC. |
| K150342 |
02/11/2015 |
Touch Ultrasound |
CARESTREAM HEALTH, INC. |
| K150766 |
03/24/2015 |
Carestream DRX-1 System |
Carestream Health, Inc. |
| K151774 |
07/01/2015 |
CARESTREAM Vue Motion |
CARESTREAM HEALTH, INC. |
| K193574 |
12/23/2019 |
Q-Rad System |
Carestream Health, Inc. |
| K152467 |
08/31/2015 |
Touch Ultrasound |
CARESTREAM HEALTH, INC. |
| K163203 |
11/15/2016 |
Carestream DRX-Evolution |
Carestream Health, Inc. |
| K090318 |
02/09/2009 |
CARESTREAM DRX-1 SYSTEM |
CARESTREAM HEALTH, INC. |
| K091186 |
04/23/2009 |
KODAK 1500 INTRAORAL CAMERA |
CARESTREAM HEALTH, INC. |
| K111649 |
06/13/2011 |
CS 7600 |
CARESTREAM HEALTH, INC. |
| K170580 |
02/28/2017 |
Carestream Vue PACS |
Carestream Health, Inc. |
| K180667 |
03/14/2018 |
SmartGrid |
Carestream Health, Inc. |
| K153103 |
10/26/2015 |
CARESTREAM Vue PACS |
CARESTREAM HEALTH, INC. |
| K191879 |
07/15/2019 |
DRX-Evolution with Carestream Digital Tomosynthesis |
Carestream Health, Inc. |
| K202441 |
08/26/2020 |
Eclipse II with Smart Noise Cancellation |
Carestream Health, Inc. |
| K192894 |
10/11/2019 |
Vita Flex CR System with LLI |
Carestream Health, Inc. |
| K090469 |
02/23/2009 |
CARESTREAM DRYVIEW 5850 LASER IMAGER |
CARESTREAM HEALTH, INC. |
| K213307 |
10/04/2021 |
Eclipse II with Smart Noise Cancellation |
Carestream Health, Inc. |
| K183245 |
11/21/2018 |
Carestream DRX-1 System with DRX Plus 2530 Detectors |
Carestream Health, Inc. |
| K223842 |
12/22/2022 |
DRX - Compass |
Carestream Health, Inc. |
| K110919 |
04/01/2011 |
CARESTREAM PACS |
CARESTREAM HEALTH, INC. |
| K083673 |
12/11/2008 |
CARESTREAM PACS, MODEL CARESTREAM PACS VII |
CARESTREAM HEALTH, INC. |
| K170755 |
03/13/2017 |
DRX-Revolution Nano Mobile X-ray System |
Carestream Health, Inc. |
| K153142 |
10/30/2015 |
Carestream DRX-1 System with DRX Plus 4343 Detectors |
CARESTREAM HEALTH, INC. |
| K183474 |
12/17/2018 |
Carestream DRX-1 System with DRX Core Detectors |
Carestream Health, Inc. |
| K173478 |
11/13/2017 |
OnSight 3D Extremity System |
Carestream Health, Inc. |
| K173924 |
12/26/2017 |
DRX-Revolution Nano Mobile X-ray System |
Carestream Health, Inc. |
|
|
