FDA.reportPublic FDA data

FUJIFILM CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30017229283001722928FUJIFILM CORPORATION1N2026-01-01798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN Kanagawa JP 258-8538

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109141138100001P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE2017-01-10
109141055005030P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)MUE2006-07-10
109141899343917K962967FUJI MEDICAL DRY IMAGER FM-DP 2636LMC1996-10-28
109141586435478K954707BRONCHOSCOPEEOQ1995-11-22
109141138357890K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMFET1995-04-11
109141251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
109141770915558K862414FUJI CR IMAGING PLATEEAM1987-02-26
109141573354717K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET2026-07-02
109141354690595K260595Sonosite iLOOK Ultrasound SystemIYN2026-03-10
109142025706620K260567EW10-EC02 Endoscopy Support ProgramQNP2026-08-07
109141529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
109141774381074K254075Synapse Lung Nodule AIOEB2026-05-27
109141008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
109141371061169K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF2023-09-08
109141046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
109141464925984K212956FDR Cross (DR-XD 3000)OWB2021-11-08
109141926006649K212873Aspire CristalleMUE2022-05-27
109141082036951K200973Synapse 3D Cardiac ToolsLLZ2020-08-27
109141036722099K200668DR-ID 1200SDK SystemMQB2020-04-10
109141105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
109141399004824K192932FDR D-EVO III flat panel detector systemMQB2019-11-12
109142066036206K192918Video Laparoscope, Video Processor, Light SourceGCJ2020-02-20
109141878814343K192664FUJIFILM Endoscope Model EC-760Z-V/LFDF2019-11-20
109141210504442K192440FDR SE LiteMQB2019-11-01
109141094671375K191747FUJIFILM Duodenoscope Model ED-580XTFDT2019-09-27
109141635842931K191544Synapse 3D Blood Flow AnalysisLLZ2019-10-18
109141383079122K191495Biopsy PositionerIZH2019-07-03
109141888745235K190649FUJIFILM Endoscope Model EC-760S-V/LFDF2019-05-07
109141297978711K183686FUJIFILM Endoscope Model EG-530NFDS2019-02-28
109141675936413K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA2019-02-27
109141782321785K183607FUJIFILM BronchoscopeEOQ2019-08-23
109141142341819K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDS2019-07-16
109142033226837K183433FUJIFILM Ultrasonic EndoscopeODG2019-09-05
109141988195884K183032FUJIFILM Double Balloon Endoscope EI580BTFDA2019-06-24
109142024355996K182836FUJIFILM Endoscope Model EG-740NFDS2019-04-02
109141374964734K182825FUJIFILM Ultrasonic EndoscopeEOQ2019-02-22
109141246376720K182253FUJIFILM Video BronchoscopesEOQ2019-04-04
109141308498357K182051FUJIFILM Duodenoscope ModelFDT2018-10-02
109142042959559K181773Synapse 3D Optional ToolsLLZ2018-09-25
109141553784781K181763FUJIFILM Ultrasonic EndoscopeFDS2018-07-27
109141411260326K181745FUJIFILM Duodenoscope ModelFDT2019-03-28
109141324522040K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX2018-05-25
109141101825694K180405FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF2018-03-15
109141408728363K180341FUJIFILM 600 Series Endoscope EG-600WR v2FDS2018-08-03
109141025164739K173132ASPIRE CristalleMUE2017-10-27
109141981123637K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDS2018-03-01
109141419018887K171463ASPIRE Bellus IILLZ2017-09-29
109141625805761K171291FUJIFILM Bronchoscope Model EB-530PEOQ2018-01-19
109141602989950K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MODG2018-01-11
109141646555647K171096Fujifilm Diathermic Slitter (FlushKnife)KGE2017-05-09
109141725126968K170858FDR AQRO (DR-XD 1000)IZL2017-04-24
109141287779119K170451FDX Console (DR-ID300CL) SoftwareLLZ2017-03-16
109142073204883K170084InterLock TrocarGCJ2017-03-10
109141134918303K163675Processor VP-7000, Light Source BL-7000FET2017-04-25
109141823444649K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)MQB2017-06-30
109141629067233K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDS2017-06-15
109141734472871K162287Synapse 3D Perfusion AnalysisLLZ2017-04-06
109141244337184K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGE2016-06-29
109141399033402K160196Fujifilm Video Colonoscope Model EC-600WL V2FDF2016-02-23
109141560875192K153483Balloon controller PB-30FDF2015-12-15
109142063718758K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1FDS2016-03-03
109141229602879K152257Fujifilm Duodenoscope Model ED-530XTFDT2017-07-21
109141462203752K152138FDR D-EVO GL Flat Panel Detector SystemMQB2015-11-05
109141787796892K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)KGE2016-02-18
109142044002427K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFDF2015-07-06
109141355504781K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDA2015-08-20
109141741124380K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFDS2015-05-14
109141189046698K142521Synapse 3D Liver and Kidney AnalysisLLZ2014-12-01
109141652599178K142003FDR D-EVO II FLAT PANEL DETECTOR SYSTEMMQB2014-10-21
109141518580140K141514SYNAPSE 3D TENSOR ANALYSISLLZ2014-09-03
109141496239344K140149EPX-4440HD DIGITAL VIDEO PROCESSORPEA2014-08-22
109142064113515K133976FUJIFILM ENDOSCOPIC CO2 REGULATORFCX2014-09-09
109141004766632K133972ASPIRE CRISTALLEMUE2014-03-25
109141227453108K132210FUJIFILM 600 SERIES ENDOSCOPESFDF2014-01-10
109141669919615K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISLLZ2013-06-14
109141454941324K130383SYNAPSE 3D CARDIAC TOOLSLLZ2013-04-09
109141880271689K123566SYNAPSE 3D COLON ANALYSISLLZ2013-01-22
109141407891911K122535FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530HEOQ2012-12-13
109141311053725K122454FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTIONKPR2012-11-20
109141746764488K121499FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEMIZF2012-11-20
109142005327177K121035FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530USEOQ2012-06-04
109141074364818K120679SYNAPSE 3D NODULE ANALYSISLLZ2012-06-01
109141441363051K120637SYNAPSE 3D BRAIN PERFUSIONLLZ2012-05-08
109141340785669K120629FDR GO FLEXMQB2012-08-28
109141174666771K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2FDS2012-08-13
109141269746559K120361SYNAPSE 3D BASE TOOLSLLZ2012-04-06
109141226709967K113244SYNAPSE MPR FUSIONLLZ2011-12-22
109142037499349K112391FUJINON COLONOSCOPESFDF2012-07-26
109141929855380K111865WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATUREMQB2011-09-30
109141434414410K111646ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCRMUE2011-12-08
109141373555611K111548WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SEMQB2011-08-30
109141094374454K111243FUJINON ULTRASONIC PROCESSORFDS2011-05-16
109141470336185K102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORFET2011-05-25
109141799631802K091773FUJINON STERILE OVERTUBESFED2009-08-07
109141051263827K090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15FDF2009-04-22
109142046983520K081308FUJIFILM FCR VIEW, MODEL CR-VW674LLZ2008-06-04
109141031479503K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZL2008-05-14
109141165598368K070920FUJI IP CASSETTE TYPE PCIYE2007-05-22
109141943630511K063316FUJINON MODEL EG-530N TRANS NASAL INSERTIONFDS2007-03-16
109141901015991K050907FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270PEOQ2005-05-19
109142059226931K042043FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5FDS2004-11-24
109141814508714K042023FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READERMQB2004-08-25
109141813273964K041903FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5FDF2004-11-10
109141792284813K040048FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEMFDA2004-06-07
109141150646289K033561FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READERMQB2003-11-26
109141343230116K033377FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP LLMC2004-01-09
109141301674943
109141543307878
109141646774254
109141877160305
109141977896060
109141200819195
109141974459109

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ202022-11-10
FDS142019-12-11
FDF112023-09-08
MQB112020-04-10
EOQ82019-08-23
FET52026-07-02
MUE42022-05-27
FDT42019-09-27
FDA42019-06-24
KGE32017-05-09
QIH22026-04-30
GCJ22020-02-20
ODG22019-09-05
FCX22018-05-25
IZL22017-04-24
LMC22004-01-09
QNP12026-08-07
OEB12026-05-27
IYN12026-03-10
OWB12021-11-08
IZH12019-07-03
OTE12017-01-10
PEA12014-08-22
IZF12012-11-20
KPR12012-11-20
FED12009-08-07
IYE12007-05-22
EAM11987-02-26

PMN#

53 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next