FDA.reportPublic FDA data

Ge-Healthcare-Japan-Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96122833002808529GE Healthcare Japan Corporation1N2026-01-017-127, Asahigaoka 4-chome HINO-SHI Tokyo JP 191-8503

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266051994938556K991716HISPEED NX/I CT SCANNER SYSTEMJAK1999-06-18
266051667739365K980176HISPEED QX/I CT SCANNER SYSTEMJAK1998-04-13
266051288921104K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMSJAK1998-04-13
266051147122009K963896MOBILE CT PROSPEED FAMILYJAK1996-12-18
266051812425088K921192CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEMJAK1992-10-20
266051686113718K913485CT SYTEC 8000JAK1992-01-23
266051254576328K911387CT SYTEC 4000JAK1991-05-09
266051717034491K893820CT SYTEC 3000JAK1989-08-07
266051532268600K882581CT MAX 640 #B7940 JA/JEJAK1988-08-15
266051861477927K872526CT PACE CATALOG NUMBER B7950AJAK1987-09-23
266051508641653K862317CT MAX, CATALOG NO. B7940 HAJAK1986-10-07
266051474458767K843927CT 9000JAK1984-12-17
266051228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
266052053786010K260398LOGIQ eIYN2026-05-26
266051119048953K253686True Definition DLJAK2026-03-23
266051695495357K253370LOGIQ TotusIYN2026-01-08
266051684322365K253366LOGIQ FortisIYN2026-01-07
266051111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266052053695773K251985LOGIQ E10IYN2025-10-29
266051078030117K251963LOGIQ E10sIYN2025-10-29
266051846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266051040314840K251169Vivid PioneerIYN2025-07-10
266051833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
266051273874788K243628Vivid T9/Vivid T8IYN2025-02-11
266051905736941K243620Vivid iqIYN2025-02-11
266051519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
266051955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
266051829127751K240111VenueIYN2024-06-10
266051060568579K240053Venue GoIYN2024-06-10
266051574908925K234106Venue FitIYN2024-06-10
266051921203345K233698True Enhance DLJAK2024-04-11
266051414324903K233692Voluson Signature 20, Voluson Signature 18IYN2024-03-07
266051233237274K232381LOGIQ TotusIYN2023-12-07
266051507556663K232186LOGIQ eIYN2023-11-03
266051680768656K231989LOGIQ E10s, LOGIQ FortisIYN2023-11-07
266051803846471K231966LOGIQ E10IYN2023-11-07
266051113056635K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2023-10-30
266051504428246K230807Deep Learning Image ReconstructionJAK2023-04-20
266051146882666K230346Voluson SWIFT; Voluson SWIFT+IYN2023-06-20
266051550945944K223832Vivid S60N, Vivid S70NIYN2023-02-16
266051484427763K223407Versana EssentialIYN2023-02-15
266051496863674K221148Vivid iqIYN2022-07-18
266051355744278K221147Vivid T8, Vivid T9IYN2022-07-18
266051122088303K220961Deep Learning Image ReconstructionJAK2022-07-29
266051849210467K220882Vivid E80, Vivid E90, Vivid E95IYN2022-07-22
266051470155993K220851VenueIYN2022-06-27
266051207379269K220848Venue FitIYN2022-06-27
266051255747394K220800Venue GoIYN2022-06-21
266051583853416K220619Vivid S60N, Vivid S70NIYN2022-07-15
266051271216718K220446Versana BalanceIYN2022-05-11
266051542794144K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2022-06-06
266051665287961K214039LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2022-03-22
266051290633536K213938Revolution AscendJAK2022-02-04
266051395009610K213689Voluson P6, Voluson P8IYN2022-02-17
266051871704527K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN2022-01-13
266051847928774K212067Deep Learning Image ReconstructionJAK2021-09-17
266051828249342K211524LOGIQ E10s, LOGIQ FortisIYN2021-08-27
266051373506904K211488LOGIQ E10IYN2021-09-10
266051215438851K211216Vivid S60N / Vivid S70NIYN2021-06-09
266051054366508K210438Versana PremierIYN2021-09-10
266051308005184K203169Revolution AscendJAK2020-11-20
266051045794044K203137Venue FitIYN2020-12-29
266051860949993K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2021-01-08
266052049977122K202658Vivid E80/ Vivid E90/ Vivid E95IYN2021-03-05
266051320605005K202233Venue GoIYN2020-11-18
266051480472745K202132VenueIYN2020-11-13
266051565719312K201828Voluson SWIFT, Voluson SWIFT+IYN2020-10-11
266051552540714K200998Versana ActiveIYN2020-06-11
266051085334430K200851Vivid T8, Vivid T9IYN2020-09-09
266051657862593K200743Vivid E80/ Vivid E90/ Vivid E95IYN2020-07-23
266051803578892K200708Vivid iqIYN2020-09-09
266051041951822K200497Vivid S60N, Vivid S70NIYN2020-07-16
266051736355325K200158LOGIQ E10IYN2020-04-17
266051615631748K200138Versana PremierIYN2020-07-01
266051862225688K200119LOGIQ E10sIYN2020-04-01
266051461674709K193170Deep Learning Image ReconstructionJAK2019-12-13
266051545666808K192159Voluson E6, Voluson E8, Voluson E10IYN2019-08-29
266051392054813K191798Versana ActiveIYN2019-08-09
266051045577832K191792Versana BalanceIYN2019-08-09
266051457689308K183362Venue GOIYN2019-01-28
266051901623583K182450Vivid S60N, Vivid S70NIYN2018-10-19
266052014006386K182277Versana PremierIYN2018-11-21
266051975945052K181985Voluson E6, Voluson E8, Voluson E10IYN2018-11-15
266051745719114K181934Vivid T8, Vivid T9IYN2018-11-06
266052007831697K181783LOGIQ P9; LOGIQ P7IYN2018-09-20
266051565149051K181727Vivid iqIYN2018-12-06
266051649812527K181685Vivid E80, Vivid E90, Vivid E95IYN2018-10-25
266051426315530K180599VenueIYN2018-05-02
266051355669882K180535Voluson P6 and Voluson P8IYN2018-03-29
266051206091853K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertIYN2018-03-13
266051260621496K173555LOGIQ E10IYN2017-12-20
266051153581817K173341Vivid E80, Vivid E90, Vivid E95IYN2017-11-02
266051018031851K172342Voluson E6, Voluson E8, Voluson E10IYN2017-09-29
266051468837388K170878Vivid S60N, Vivid S70NIYN2017-06-14
266051449109060K170823Vivid E80, Vivid E90, Vivid E95IYN2017-06-12
266051133032998K170714VenueIYN2017-06-21
266051574494153K170445LOGIQ S8IYN2017-04-11
266051454914260K163596LOGIQ P9 and LOGIQ P7IYN2017-02-10
266051883730630K163213Revolution CTJAK2016-12-16
266051325329541K163077LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2016-11-17
266051049862273K162269Voluson E6, Voluson E8, Voluson E10IYN2016-10-03
266051081354306K161706Vivid iqIYN2016-08-05
266051135478901K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3IYN2016-08-05
266051317418062K161047LOGIQ P9 and LOGIQ P7IYN2016-05-05
266051985183816K160621SIGNAPioneerLNH2016-03-29
266051879277666K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6IYN2016-03-25
266051757886243K160184Voluson S6, Voluson S8, Voluson S10IYN2016-02-25
266051599852132K160182LOGIQ S7 ExpertIYN2016-02-26
266051068620599K160162Voluson P6, Voluson P8IYN2016-04-26
266051696609696K160078Vivid T8IYN2016-03-10
266051350387500K153037LOGIQ V1/ LOGIQ V2IYN2016-01-04
266051395401869K153003SIGNA PioneerLNH2015-10-27
266051045509035K152758Venue 50IYN2015-11-18
266051319113126K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemIYN2015-11-06
266051246173604K152309LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2015-09-14
266051327741506K152195LOGIQ S8IYN2015-09-29
266051207496007K151372Low Dose CT Lung Cancer Screening Option for Qualified GE SystemsJAK2015-08-14
266051664569213K151028LOGIQ eIYN2015-06-18
266051491990043K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemIYN2015-03-04
266051524790521K143452LOGIQ P9, LOGIQ P7IYN2015-01-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1502026-05-26
JAK332026-03-23
IYO82012-04-19
LNH32016-03-29
ITX32012-10-05

PMN#

GUDID#

NA - 8C-RS

GE Healthcare Japan Corporation

2016-07-15

NA - M4S-D

GE Healthcare Japan Corporation

2016-07-15

DLIR - 1.0

GE Healthcare Japan Corporation

2020-02-21

MAR - 1.0

GE Healthcare Japan Corporation

2017-10-25

NA - 4Vc-D

GE Healthcare Japan Corporation

2017-11-21

NA - ERB

GE Healthcare Japan Corporation

2016-07-15

NA - MTZ

GE Healthcare Japan Corporation

2016-07-15

NA - LE

GE Healthcare Japan Corporation

2016-07-15

NA - C721

GE Healthcare Japan Corporation

2016-07-15

NA - C31

GE Healthcare Japan Corporation

2016-07-15

NA - C358

GE Healthcare Japan Corporation

2016-07-15

NA - LD

GE Healthcare Japan Corporation

2016-07-15

NA - L76

GE Healthcare Japan Corporation

2016-07-15

NA - 3C-RS

GE Healthcare Japan Corporation

2016-07-15

NA - CS

GE Healthcare Japan Corporation

2016-07-15

NA - CAE

GE Healthcare Japan Corporation

2016-07-15

NA - C55

GE Healthcare Japan Corporation

2016-07-15

NA - T739

GE Healthcare Japan Corporation

2016-07-15

NA - I739

GE Healthcare Japan Corporation

2016-07-15

NA - C551

GE Healthcare Japan Corporation

2016-07-15

NA - LB

GE Healthcare Japan Corporation

2016-07-15

NA - 12L

GE Healthcare Japan Corporation

2016-07-15

NA - 10L

GE Healthcare Japan Corporation

2016-07-15

NA - 7L

GE Healthcare Japan Corporation

2016-07-15

NA - M7C-H

GE Healthcare Japan Corporation

2016-07-15

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