FDA.report

Carestream Health, Inc.

Matched from indexed company URL: Carestream Health

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
13172671317267Carestream Health, Inc.1N2026-01-011669 Lake Avenue Rochester NY US 14652
13173071317307Carestream Health, Inc1Y2026-01-011049 West Ridge Road Rochester NY US 14615
30299111000524463Carestream Health, Inc.1Y2026-01-018124 Pacific Ave WHITE CITY OR US 97503
30041054753004105475Carestream Healthcare International Company, Ltd1N2026-01-01Building 7, No. 1510 Chuanqiao Road China (Shanghai) Pilot Free Trade Zone Shanghai CN 201206
30155325253015532525CARESTREAM HEALTH, INC.1Y2026-01-01882 Linden Ave. Rochester NY US 14625
17184321718432Carestream Health, Inc.1Y2020-04-252000 Howard Smith Avenue West Windsor CO US 80550
21339293002095347CARESTREAM HEALTH, INC.1Y2020-04-251 IMATION WAY OAKDALE MN US 55128
30064506243006450624CARESTREAM HEALTH, INC.1Y2020-04-251600 Lexington Ave Rochester NY US 14652
30116819863011681986Carestream Health, Inc.1N2020-04-255450 Campus Drive Canandaigua NY US 14424

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
678191001143994P080018KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHYMUE2010-11-03
678251190362892K972163IMATION SE-196 LASER IMAGERLMC1997-09-05
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
1483822067410852K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableOWN2019-11-19
1483821287627554K192174SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2019-11-15
1483821337246634K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMOWN2019-05-10
1483821938799129K182907SPY Elite Intraoperative Perfusion Assessment SystemIZI2019-01-23
1483821270811341K182606PINPOINT Endoscopic Fluorescence Imaging SystemGCJ2018-11-21
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
1846961837579856K153142Carestream DRX-1 System with DRX Plus 4343 DetectorsMQB2015-11-25
1846961541696230K150766Carestream DRX-1 SystemMQB2015-06-24
678191541696230K150766Carestream DRX-1 SystemMQB2015-06-24
678191229586365K150342Touch UltrasoundIYO2015-05-08
1846961097380521K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTORMQB2013-06-07
678191097380521K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTORMQB2013-06-07
1483821395275629K123013ENDOSCOPIC INTRODUCERFED2013-03-22
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
678251817585049K090469CARESTREAM 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
1483821167462388K071619SPY FLUORESCENT IMAGING SYSTEMIZI2007-11-09
1483821572032432K071037SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000IZI2007-05-10
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
678171917934637
678251917934637
678191924158527
678252062245003
678252063292547
678232063292547
678191005438946
678191171137449
2349481270811341
2349481287627554
2349481337246634
3509681766535397
678191777891833
678231917934637
678191917934637
678181917934637
2349481938799129
2349482067410852

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MQB152025-10-09
IXA52004-05-24
KPR42026-01-20
LLZ42017-04-11
IZL32026-03-11
OWN32019-11-19
IZI32019-01-23
LMC32009-05-22
GCJ12018-11-21
JAK12016-08-30
IYO12015-05-08
FED12013-03-22
MUE 12010-11-03
IYE11996-05-28

PMA

PMN

50 records. Showing 1-40. Next

GUDID

80 records. Showing 1-40. Next