FDA.reportPublic FDA data

Ge-Medical-Systems-Ultrasound

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21830662183066GE Medical Systems Ultrasound & Primary Care Diagnostics LLC1Y2026-01-013030 Ohmeda Drive MADISON WI US 53718
30021830743002183074GE Medical Systems Ultrasound & Primary Care Diagnostics LLC1Y2026-01-0114470 Bergen Blvd. Noblesville IN US 46060
30058607203005860720GE Medical Systems Ultrasound and Primary Care Diagnostics LLC1Y2026-01-019900 Innovation Drive Wauwatosa WI US 53226
30320080183032008018GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC1N2026-01-013200 N Grandview Blvd Waukesha WI US 53188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266611726797920P970040ACHILLES EXPRESS ULTRASONOMETERMUA1998-06-26
266021844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
3299151844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
266021020753966K993712BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMFMZ1999-11-09
266612055471170K982267DPX-RX BONE DENSITOMETERKGI1998-08-18
266611592831778K873296DPX BONE DENSITOMETERKGI1988-06-06
3299151405156630K254161Automated Aortic Stenosis Software (AutoAS)POK2026-03-27
844811695495357K253370LOGIQ TotusIYN2026-01-08
844811684322365K253366LOGIQ FortisIYN2026-01-07
266611692648950K252718Lunar AstraKGI2026-04-20
844812053695773K251985LOGIQ E10IYN2025-10-29
3299152053695773K251985LOGIQ E10IYN2025-10-29
844811078030117K251963LOGIQ E10sIYN2025-10-29
844811846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
3299151846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
844811273874788K243628Vivid T9/Vivid T8IYN2025-02-11
844811905736941K243620Vivid iqIYN2025-02-11
3299151586260182K243065Cardiac GuidanceQJU2025-01-15
844811519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
3299151369655905K240206Venue SprintIYN2024-06-10
844811829127751K240111VenueIYN2024-06-10
3299151829127751K240111VenueIYN2024-06-10
844811060568579K240053Venue GoIYN2024-06-10
3299151060568579K240053Venue GoIYN2024-06-10
844811574908925K234106Venue FitIYN2024-06-10
3299151574908925K234106Venue FitIYN2024-06-10
844811507556663K232186LOGIQ eIYN2023-11-03
844811680768656K231989LOGIQ E10s, LOGIQ FortisIYN2023-11-07
266021803846471K231966LOGIQ E10IYN2023-11-07
844811803846471K231966LOGIQ E10IYN2023-11-07
3299151803846471K231966LOGIQ E10IYN2023-11-07
844811113056635K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN2023-10-30
844811146882666K230346Voluson SWIFT; Voluson SWIFT+IYN2023-06-20
844811496863674K221148Vivid iqIYN2022-07-18
844811355744278K221147Vivid T8, Vivid T9IYN2022-07-18
844811849210467K220882Vivid E80, Vivid E90, Vivid E95IYN2022-07-22
266021470155993K220851VenueIYN2022-06-27
844811470155993K220851VenueIYN2022-06-27
266021207379269K220848Venue FitIYN2022-06-27
844811207379269K220848Venue FitIYN2022-06-27
266021255747394K220800Venue GoIYN2022-06-21
844811255747394K220800Venue GoIYN2022-06-21
844811583853416K220619Vivid S60N, Vivid S70NIYN2022-07-15
844811665287961K214039LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2022-03-22
844811395009610K213689Voluson P6, Voluson P8IYN2022-02-17
844811871704527K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertIYN2022-01-13
844811828249342K211524LOGIQ E10s, LOGIQ FortisIYN2021-08-27
266021373506904K211488LOGIQ E10IYN2021-09-10
844811373506904K211488LOGIQ E10IYN2021-09-10
844811215438851K211216Vivid S60N / Vivid S70NIYN2021-06-09
3299151915366527K210747Caption Interpretation Automated Ejection Fraction SoftwareQIH2022-01-19
266021045794044K203137Venue FitIYN2020-12-29
844811860949993K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYN2021-01-08
266021320605005K202233Venue GoIYN2020-11-18
844811320605005K202233Venue GoIYN2020-11-18
266021480472745K202132VenueIYN2020-11-13
844811480472745K202132VenueIYN2020-11-13
844811552540714K200998Versana ActiveIYN2020-06-11
844811657862593K200743Vivid E80/ Vivid E90/ Vivid E95IYN2020-07-23
844811803578892K200708Vivid iqIYN2020-09-09
266021736355325K200158LOGIQ E10IYN2020-04-17
844811736355325K200158LOGIQ E10IYN2020-04-17
844811615631748K200138Versana PremierIYN2020-07-01
266021545666808K192159Voluson E6, Voluson E8, Voluson E10IYN2019-08-29
844811545666808K192159Voluson E6, Voluson E8, Voluson E10IYN2019-08-29
266612058508042K191112GEHC DXA Bone Densitometers with enCORE version 18KGI2019-09-19
266021457689308K183362Venue GOIYN2019-01-28
844811901623583K182450Vivid S60N, Vivid S70NIYN2018-10-19
266021975945052K181985Voluson E6, Voluson E8, Voluson E10IYN2018-11-15
844811975945052K181985Voluson E6, Voluson E8, Voluson E10IYN2018-11-15
266021565149051K181727Vivid iqIYN2018-12-06
844811565149051K181727Vivid iqIYN2018-12-06
844811649812527K181685Vivid E80, Vivid E90, Vivid E95IYN2018-10-25
266611487736266K180782AriaKGI2018-04-20
266021341501258K180641Invenia ABUS ViewerLLZ2018-05-04
3299151341501258K180641Invenia ABUS ViewerLLZ2018-05-04
266021426315530K180599VenueIYN2018-05-02
844811426315530K180599VenueIYN2018-05-02
266021260621496K173555LOGIQ E10IYN2017-12-20
844811153581817K173341Vivid E80, Vivid E90, Vivid E95IYN2017-11-02
266021018031851K172342Voluson E6, Voluson E8, Voluson E10IYN2017-09-29
844811018031851K172342Voluson E6, Voluson E8, Voluson E10IYN2017-09-29
844811449109060K170823Vivid E80, Vivid E90, Vivid E95IYN2017-06-12
266021133032998K170714VenueIYN2017-06-21
844811133032998K170714VenueIYN2017-06-21
266021574494153K170445LOGIQ S8IYN2017-04-11
844811454914260K163596LOGIQ P9 and LOGIQ P7IYN2017-02-10
266021325329541K163077LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2016-11-17
844811325329541K163077LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2016-11-17
3299151325329541K163077LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2016-11-17
266021049862273K162269Voluson E6, Voluson E8, Voluson E10IYN2016-10-03
844811049862273K162269Voluson E6, Voluson E8, Voluson E10IYN2016-10-03
266021081354306K161706Vivid iqIYN2016-08-05
266611082505773K161682GE Lunar DXA Bone Densitometers with enCORE version 17KGI2016-12-02
844811317418062K161047LOGIQ P9 and LOGIQ P7IYN2016-05-05
266021599852132K160182LOGIQ S7 ExpertIYN2016-02-26
844811696609696K160078Vivid T8IYN2016-03-10
266021045509035K152758Venue 50IYN2015-11-18
844811045509035K152758Venue 50IYN2015-11-18
266021319113126K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemIYN2015-11-06
844811319113126K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemIYN2015-11-06
266021246173604K152309LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2015-09-14
844811246173604K152309LOGIQ E9, LOGIQ E9 XDClear 2.0IYN2015-09-14
266021327741506K152195LOGIQ S8IYN2015-09-29
266021664569213K151028LOGIQ eIYN2015-06-18
844811664569213K151028LOGIQ eIYN2015-06-18
266021017684941K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsIYN2015-02-10
266021253903947K142160LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-10-10
844811253903947K142160LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-10-10
844811506431334K141675VOLUSON P6, VOLUSON P8IYN2014-07-25
844811071929123K141639VOLUSON S6, VOLUSON S8IYN2014-07-18
266021358923234K141261LOGIQ S7 EXPERT, LOGIQ S7 PROIYN2014-06-05
844811358923234K141261LOGIQ S7 EXPERT, LOGIQ S7 PROIYN2014-06-05
266611707517346K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSKGI2014-05-15
266022007487350K133533LOGIQ EIYN2014-02-12
266021143881808K132913VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10IYN2013-11-08
844811313434568K131937VOLUSON I/EIYN2013-09-24
266021412435246K131527LOGIQ S8IYN2013-08-26
844811412435246K131527LOGIQ S8IYN2013-08-26
844811605730960K131514GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYN2013-07-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1502026-01-08
KGI92026-04-20
IYO72012-04-19
QJU22025-01-15
LLZ22018-05-04
PAA22012-09-18
POK12026-03-27
QVD12023-02-24
QIH12022-01-19
ITX12012-08-17
FMZ11999-11-09
MUA 11998-06-26

PMN#

LOGIQ Totus

2026-01-08

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Fortis

2026-01-07

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10s

2025-10-29

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid Pioneer

2025-07-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vscan Air

2025-05-01

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid iq

2025-02-11

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid T9/Vivid T8

2025-02-11

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue Go

2024-06-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue Fit

2024-06-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue Sprint

2024-06-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

Venue

2024-06-10

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ Totus

2023-12-07

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ E10

2023-11-07

GE Medical Systems Ultrasound and Primary Care Diagnostics

LOGIQ e

2023-11-03

Ge Medical Systems Ultrasound and Primary Care Diagnostic,

Vscan Air

2023-08-15

GE Medical Systems Ultrasound and Primary Care Diagnostics

Versana Essential

2023-02-15

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vivid Iq

2022-07-18

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Venue Go

2022-06-21

GE Medical Systems Ultrasound And Primary Care Diagnostics

Versana Balance

2022-05-11

GE Medical Systems Ultrasound And Primary Care Diagnostics,

Versana Premier

2021-09-10

GE Medical Systems Ultrasound And Primary Care Diagnostics,

ViewPoint 6

2021-01-15

GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC

Venue Fit

2020-12-29

GE Medical Systems Ultrasound And Primary Care Diagnostics,

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