FDA.reportPublic FDA data

Carestream Health, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13173071317307Carestream Health, Inc1Y2026-01-011049 West Ridge Road Rochester NY US 14615

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
678191001143994P080018KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHYMUE2010-11-03
678191087907945K960834KODAK EC-L CASSETTEIYE1996-05-28
678191261349433K945039MCI OPTONIX CASSETTE OKAMOTO CASSETEIXA1994-11-22
678191207070194K896708PERLINK CASSETTE, KIRAN CASSETTEIXA1990-05-07
678191719841891K890750KODAK X-OMATIC RA CASSETTEIXA1989-03-01
678191943769218K890361KODAK MIN-R 2 CASSETTEIXA1989-02-24
678191640544986K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL2026-03-11
678191211893988K252911Lux HD 2530 detector (Lux HD 2530)MQB2025-10-09
678191259804588K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorKPR2026-01-20
678191463947702K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB2025-03-18
678191509476711K213646Focus HD 35 DetectorMQB2022-03-29
678191254802843K213529Focus HD 43 DetectorMQB2022-03-29
678191920704129K200622Focus 43C detector, TRIMAX 43C detectorMQB2020-04-01
678191166155389K192512Focus 35C Detector, Trimax 35C DetectorMQB2019-10-16
678191705625014K173924DRX-Revolution Nano Mobile X-ray SystemIZL2018-02-05
678191244692247K170580Carestream Vue PACSLLZ2017-04-11
678191866988392K160723OnSight 3D Extremity SystemJAK2016-08-30
678191837579856K153142Carestream DRX-1 System with DRX Plus 4343 DetectorsMQB2015-11-25
678191541696230K150766Carestream DRX-1 SystemMQB2015-06-24
678191229586365K150342Touch UltrasoundIYO2015-05-08
678191097380521K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTORMQB2013-06-07
678191988755381K120062DRX-REVOLUTION MOBILE X-RAY SYSTEMIZL2012-04-13
678191056897593K110919CARESTREAM PACSLLZ2011-10-20
678191813101895K100094CARESTREAM IMAGE SUITELLZ2010-03-11
678191499063760K091889DRX-EVOLUTION, MODEL VX3733-SYSKPR2009-07-20
678191817585049K090469CARESTREAM DRYVIEW 5850 LASER IMAGERLMC2009-05-22
678191763511961K090318CARESTREAM DRX-1 SYSTEMMQB2009-04-06
678191371587195K081836CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEMKPR2008-07-30
678191632154667K073169SCIMAGE PICOMENTERPRISELLZ2008-01-09
678191456559938K040378KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253IXA2004-05-24
678191512067957K021829MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEMMQB2002-07-02
678191686113745K020635KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976MQB2002-03-21
678191406693184K011486Q-RAD RADIOGRAPHIC SYSTEMKPR2001-06-20
678191363049322
678191701606637
678191924158527
678191005438946
678191171137449
678191777891833
678191917934637

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB122025-10-09
IXA52004-05-24
KPR42026-01-20
LLZ42017-04-11
IZL32026-03-11
JAK12016-08-30
IYO12015-05-08
MUE 12010-11-03
LMC12009-05-22
IYE11996-05-28

PMN#