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Carestream Health, Inc.

48 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Image Suite (K251168)Carestream Health, Inc.2025-09-04
DRX-Revolution Mobile X-ray System (K241505)Carestream Health, Inc.2024-12-10
DRX-Evolution Plus System (K233381)Carestream Health, Inc.2024-03-12
DRX - Compass (K223842)Carestream Health, Inc.2023-01-20
Eclipse II with Smart Noise Cancellation (K213307)Carestream Health, Inc.2022-01-14
Eclipse II with Smart Noise Cancellation (K202441)Carestream Health, Inc.2021-04-02
DRX-Compass (K201373)Carestream Health, Inc.2020-06-26
Vita Flex CR System with LLI (K192894)Carestream Health, Inc.2020-02-18
Q-Rad System (K193574)Carestream Health, Inc.2020-01-22
DRX-Evolution with Carestream Digital Tomosynthesis (K191879)Carestream Health, Inc.2019-12-20
DRX-Evolution/Plus with Dual Energy (K190330)Carestream Health, Inc.2019-11-04
DRX-Revolution Mobile X-ray System (K191025)Carestream Health, Inc.2019-05-17
Carestream DRX-1 System with DRX Plus 2530 Detectors (K183245)Carestream Health, Inc.2019-02-08
Carestream DRX-1 System with DRX Core Detectors (K183474)Carestream Health, Inc.2019-01-16
Eclipse II (K180809)Carestream Health, Inc.2018-06-21
SmartGrid (K180667)Carestream Health, Inc.2018-04-13
DRX-Revolution Nano Mobile X-ray System (K173924)Carestream Health, Inc.2018-02-05
OnSight 3D Extremity System (K173478)Carestream Health, Inc.2018-01-19
DRX-Revolution Nano Mobile X-ray System (K170755)Carestream Health, Inc.2017-06-21
Carestream Vue PACS (K170580)Carestream Health, Inc.2017-04-11
Carestream DRX-Evolution (K163203)Carestream Health, Inc.2016-12-13
OnSight 3D Extremity System (K160723)Carestream Health, Inc.2016-08-30
CARESTREAM Vue PACS (K153103)Carestream Health, Inc.2016-02-12
Touch Ultrasound (K152467)Carestream Health, Inc.2015-12-09
Carestream DRX-1 System with DRX Plus 4343 Detectors (K153142)Carestream Health, Inc.2015-11-25
CARESTREAM Vue Motion (K151774)Carestream Health, Inc.2015-09-21
Carestream DRX-1 System (K150766)Carestream Health, Inc.2015-06-24
Touch Ultrasound (K150342)Carestream Health, Inc.2015-05-08
DRX-EVOLUTION (K141837)Carestream Health, Inc.2015-03-11
TABLET VIEWER SOFTWARE FOR IMAGE SUITE (K140271)Carestream Health, Inc.2014-04-01
BONE SUPPRESSION SOFTWARE (K133442)Carestream Health, Inc.2014-03-11
CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION (K132824)Carestream Health, Inc.2014-02-06
DR LONG LENGTH IMAGING SOFTWARE (K130567)Carestream Health, Inc.2013-06-11
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR (K130464)Carestream Health, Inc.2013-06-07
CARESTREAM VUE PACS (K122523)Carestream Health, Inc.2012-10-23
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) (K120246)Carestream Health, Inc.2012-08-28
DRX-REVOLUTION MOBILE X-RAY SYSTEM (K120062)Carestream Health, Inc.2012-04-13
CS 1600 INTRAORAL CAMERA (K111423)Carestream Health, Inc.2012-03-02
CS 1200 (K112321)Carestream Health, Inc.2011-11-10
CARESTREAM PACS (K110919)Carestream Health, Inc.2011-10-20
DRYVIEW CHROMA IMAGING SYSTEM (K111566)Carestream Health, Inc.2011-10-06
CS 7600 (K111649)Carestream Health, Inc.2011-09-23
KODAK 1500 INTRAORAL CAMERA (K091186)Carestream Health, Inc.2009-08-18
DRX-EVOLUTION, MODEL VX3733-SYS (K091889)Carestream Health, Inc.2009-07-20
CARESTREAM DRYVIEW 5850 LASER IMAGER (K090469)Carestream Health, Inc.2009-05-22
CARESTREAM DRX-1 SYSTEM (K090318)Carestream Health, Inc.2009-04-06
CARESTREAM PACS, MODEL CARESTREAM PACS VII (K083673)Carestream Health, Inc.2008-12-30
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM (K081836)Carestream Health, Inc.2008-07-30

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Every clearance here is in the API, with alerts when new ones post.