FDA.reportPublic FDA data

FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office

Matched from indexed company URL: FUJIFILM HEALTHCARE CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21552155FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office1N2026-01-011250 TAKEMATSU MINAMIASHIGARA-SHI Kanagawa JP 250-0111
15280281528028FUJIFILM Healthcare Americas Corporation1Y2026-01-011959 Summit Commerce Park Twinsburg OH US 44087
10005131611000513161FUJIFILM Healthcare Americas Corporation1Y2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30035221823003522182FUJIFILM Healthcare Manufacturing Corporation MIE Office1N2026-01-012613-2, Oaza Ogohara Komono-cho, Mie-gun JP 510-1222
30037750063003775006FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office1N2026-01-012-1-3 KITAYUGUCHI HANAMAKI-SHI Iwate JP 025-0301
30049723223004972322FUJIFILM Healthcare Americas Corporation1Y2026-01-0179 TW Alexander Drive, Building 4501 Durham NC US 27709
30056259913005625991FUJIFILM Healthcare Americas Corporation1N2026-01-011100 King Georges Post Rd Edison NJ US 08837
30061617563002808127FUJIFILM Healthcare Manufacturing Corporation Sano Office1N2026-01-01700 Konaka-Cho Sano City Tochigi JP 327-0001
30084911423008491142FUJIFILM Healthcare Americas Corporation1N2026-01-0181 Hartwell Ave Ste 100 Lexington MA US 02421
30321092253032109225FUJIFILM Healthcare Manufacturing Corporation Kashiwa Office1N2026-01-012-1, Shintoyofuta Kashiwa-shi Chiba JP 277-0804

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00854904006008Synapse Radiology PACS - Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day.+018002728465xxx@xxx.xxx
00854904006015Synapse CardioVascular - Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.+018002728465xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109121138100001P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTIONOTE2017-01-10
104851758184549K982271WAKO DIRECT LDL-CMRR1998-09-22
104852026140507K963847WAKO DIRECT HDL-CJIS1996-12-24
104851539625995K960874COMPLEMENT CONTROLJJX1996-06-14
104851082753808K954145WAKO AUTOKIT CH50DAE1995-12-18
109121138357890K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEMFET1995-04-11
109121251903536K944620SERIES 400 GASTROENTEROLOGY SYSTEMFET1995-04-27
2328191277005089K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
104851619572696K871763NEFA STANDARD SOLUTION CALIBRATORJIT1987-05-26
109111770915558K862414FUJI CR IMAGING PLATEEAM1987-02-26
109121573354717K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET2026-07-02
1222661573354717K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET2026-07-02
971051919233517K261713Synapse PACS (7.6.0)QIH2026-06-18
109121529498580K254189Synapse 3D Base Tools (V7.2)QIH2026-04-30
3306481770968762K253862APERTO Lucent MRI SystemLNH2026-04-06
1222661204923294K253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFDS2026-02-06
1222661609627467K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ2026-06-16
1222661760591122K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000FDT2026-03-09
3306481970537071K251386ECHELON SynergyLNH2025-09-17
2217971966882321K251204FUJIFILM Stiffening Wire Device (SW-2000)FDA2025-09-26
1222661284731530K250863FUJIFILM Ultrasonic Endoscope EB-710USEOQ2025-12-12
1222661656224400K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS2026-02-17
3306481095101272K250370SCENARIA View Phase 5.0JAK2025-05-20
1222661250247386K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000EOQ2025-06-13
109121008171551K243762Synapse 3D Base Tools (V7.0)QIH2025-05-21
971051734642624K243647Synapse PACS (7.5)QIH2025-06-30
1222661758445747K243512FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2025-06-10
1222661873517180K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/LFDF2025-05-23
1222661373202338K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFET2025-04-11
1222661022134335K243091Over-tube (TR-1108A)FED2024-11-01
1222661633277624K242779Hood (DH-083ST)FDS2024-10-11
3306481560117658K241429ECHELON Synergy MRI SystemLNH2024-08-13
3306481308446383K240571OASIS MRI SystemLNH2024-04-12
1222661237110114K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TPFDS2024-09-04
1222661460707586K240075FUJIFILM Endoscope Model EB-710XTEOQ2024-02-07
3306481746920778K233687ECHELON Synergy V10.0LNH2024-05-03
3306481185681721K233629APERTO Lucent MRI SystemLNH2024-05-10
3306481166914806K233583FCT iSTREAM Phase 1JAK2024-04-26
1222661093949990K232314Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)FDS2023-09-01
3306481231231891K231941ARIETTA x10IYN2023-11-20
1222662067569598K231666Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX2023-12-13
1222661213528378K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FED2023-09-15
109121575143528K230751EW10-EC02 Endoscopy Support ProgramQNP2023-12-15
1222661371061169K223827FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01FDF2023-09-08
3306481402041504K223426ECHELON Synergy MRI systemLNH2023-07-13
1222662032049948K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA2023-01-11
1222661108409800K221952Endoscope Model EG-580UT and Endoscope Model EG-580URODG2022-08-04
109121046233669K221677Synapse 3D Base Tools v6.6LLZ2022-11-10
3306481760389486K221619ECHELON Oval V6.2 MRI SystemLNH2023-01-26
1222662069607745K221551FUJIFILM Endoscope Model EI-740D/SFDS2023-01-27
1222661283516450K221238FUJIFILM Ultrasonic Endoscope EG-740UTODG2022-08-19
1222661159057700K220957FUJIFILM Endoscope Model EB-710PEOQ2022-11-10
3306481901082951K220295ARIETTA 50IYN2022-04-29
1222661141448076K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIKGE2022-02-04
1222661399497193K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG2022-06-03
3306481564895720K213829SCENARIA ViewJAK2022-05-23
1222661030989348K213195Balloon BS-3FDA2021-10-29
109121464925984K212956FDR Cross (DR-XD 3000)OWB2021-11-08
109121664857413K212950FUJIFILM Video Laparoscope EL-R740M30GCJ2021-12-02
109121926006649K212873Aspire CristalleMUE2022-05-27
1222661582725825K212296Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2FDS2021-08-19
3306481887614146K211406OASIS MRI SystemLNH2021-10-07
1545131682969326K210811Dynamyx Digital Pathology SoftwareQKQ2022-03-01
1222661426083695K210162Endoscope Model EI-740D/SFDS2021-04-09
1222661675761618K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0GCJ2021-06-30
3306481230519489K202422Arietta 65IYN2020-11-04
109121852857057K202130FUJIFILM Video LaparoscopeGCJ2020-08-20
3306481893292896K202030OASIS MRI SystemLNH2020-10-21
1222661560740677K200850Fujifilm Ultrasonic ProcessorFDS2020-07-06
109121036722099K200668DR-ID 1200SDK SystemMQB2020-04-10
1222661105992656K193123FUJIFILM Distal Cap Models 33-40FDS2019-12-11
109121399004824K192932FDR D-EVO III flat panel detector systemMQB2019-11-12
109122066036206K192918Video Laparoscope, Video Processor, Light SourceGCJ2020-02-20
1222662066036206K192918Video Laparoscope, Video Processor, Light SourceGCJ2020-02-20
1222661878814343K192664FUJIFILM Endoscope Model EC-760Z-V/LFDF2019-11-20
109121210504442K192440FDR SE LiteMQB2019-11-01
1222661094671375K191747FUJIFILM Duodenoscope Model ED-580XTFDT2019-09-27
109121635842931K191544Synapse 3D Blood Flow AnalysisLLZ2019-10-18
109121383079122K191495Biopsy PositionerIZH2019-07-03
3306481212317517K191233ARIETTA 750IYN2019-08-09
3306481202615603K190841SCENARIA ViewJAK2019-09-13
1222661888745235K190649FUJIFILM Endoscope Model EC-760S-V/LFDF2019-05-07
3306481930913618K190248ARIETTA 50IYN2019-04-02
971051337460984K190232Synapse PACSLLZ2019-03-26
1222661675936413K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA2019-02-27
1222661782321785K183607FUJIFILM BronchoscopeEOQ2019-08-23
1222661142341819K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFDS2019-07-16
3306481664306909K183456Aloka Arietta 850IYN2019-01-28
971051800436475K183248Synapse Enterprise Viewer Version 1.0LLZ2019-04-25
1222661988195884K183032FUJIFILM Double Balloon Endoscope EI580BTFDA2019-06-24
1222662024355996K182836FUJIFILM Endoscope Model EG-740NFDS2019-04-02
1222661374964734K182825FUJIFILM Ultrasonic EndoscopeEOQ2019-02-22
1222661246376720K182253FUJIFILM Video BronchoscopesEOQ2019-04-04
1222661411260326K181745FUJIFILM Duodenoscope ModelFDT2019-03-28
3306481646117350K181376ARIETTA 65IYN2018-07-18
109121324522040K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX2018-05-25
109121025164739K173132ASPIRE CristalleMUE2017-10-27
109121981123637K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDS2018-03-01
1222661981123637K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603FDS2018-03-01
1222661625805761K171291FUJIFILM Bronchoscope Model EB-530PEOQ2018-01-19
109121602989950K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MODG2018-01-11
1222661602989950K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MODG2018-01-11
1222661646555647K171096Fujifilm Diathermic Slitter (FlushKnife)KGE2017-05-09
109121725126968K170858FDR AQRO (DR-XD 1000)IZL2017-04-24
109121134918303K163675Processor VP-7000, Light Source BL-7000FET2017-04-25
3306481399193721K163528HITACHI Supria Whole-body X-ray CT System Phase 3JAK2017-03-03
3306481156564689K163505ARIETTA PRECISIONIYN2017-05-30
2944111853247509K163505ARIETTA PRECISIONIYN2017-05-30
2217971904108323K163505ARIETTA PRECISIONIYN2017-05-30
3306481123664055K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersIYN2016-12-15
109121618171488K162836FUJIFILM Surgical SystemGCJ2017-03-13
1222661629067233K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFDS2017-06-15
3306481595287013K162583ALOKA LISENDO 880IYN2016-11-17
1222661244337184K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)KGE2016-06-29
3306482071268906K160559NOBLUS™ Ultrasound Diagnostic SystemIYN2016-10-18
971052073628828K160108Synapse PACSLLZ2016-02-03
109121560875192K153483Balloon controller PB-30FDF2015-12-15
109122063718758K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1FDS2016-03-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN232023-11-20
FDS202026-02-17
EOQ122026-06-16
LNH122026-04-06
MQB112020-04-10
FDA102025-09-26
LLZ92022-11-10
FET72026-07-02
FDF72025-05-23
GCJ72021-12-02
JAK62025-05-20
ODG52022-08-19
JIS52003-04-11
QIH42026-06-18
ITX42023-12-13
MUE42022-05-27
KGE42022-02-04
FDT32026-03-09
FED32024-11-01
FCX32018-05-25
MOS32008-02-11
JFM32007-12-07
JJX32003-02-11
NSF22011-02-23
JFY22007-08-03
IYE22007-05-22
JIX22004-11-08
JIT21987-05-26
QNP12023-12-15
QKQ12022-03-01
OWB12021-11-08
IZH12019-07-03
IZL12017-04-24
OTE12017-01-10
PEA12014-08-22
KPR12012-11-20
IZF12012-11-20
IYO12009-11-20
MRR11998-09-22
DAE11995-12-18

PMN#

GUDID#