FDA.report

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

Matched from indexed company URL: GE MEDICAL SYSTEMS

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
16511043002737156GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES1Y2026-01-01465 PAN AMERICAN DR STE 11 EL PASO TX US 79907
21227261000116747GE MEDICAL SYSTEMS, LLC1N2026-01-014855 West Electric Avenue Milwaukee WI US 53219
21266772126677GE MEDICAL SYSTEMS, LLC1Y2026-01-013000 N GRANDVIEW BLVD. Waukesha WI US 53188
21830662183066GE Medical Systems Ultrasound & Primary Care Diagnostics LLC1Y2026-01-013030 Ohmeda Drive MADISON WI US 53718
21835532183553GE MEDICAL SYSTEMS, LLC1N2026-01-013200 N GRANDVIEW BLVD WAUKESHA WI US 53188
96160473003377038GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.1N2026-01-01CALLE ESPANA No. 300 PARQUE INDUSTRIAL HUINALA APODACA Nuevo Leon MX C.P.66645
97106023003513129GE MEDICAL SYSTEMS (CHINA) CO., LTD.1N2026-01-01NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE WUXI Jiangsu CN 214028
30015702353001570235GE Medical Systems Information Technologies, Inc.1N2026-01-013114 N Grandview Blvd Waukesha WI US 53188
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
30123598773012359877GE Medical Systems Information Technologies, Inc.1N2026-01-019900 Innovation Drive Wauwatosa WI US 53226
30320080183032008018GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC1N2026-01-013200 N Grandview Blvd Waukesha WI US 53188
21248232124823GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.1Y2020-04-258200 W TOWER AVE Milwaukee WI US 53223

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266611726797920P970040ACHILLES EXPRESS ULTRASONOMETERMUA 1998-06-26
3299151844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
266241844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
266021844139467P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)PAA2012-09-18
266131203649944K993757SOLAR 7/8000DSI2000-03-23
266021020753966K993712BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEMFMZ1999-11-09
266071089787345K993665LEGEND CRF FLUORO AND RAD SYSTEMKPR1999-11-12
2392561769681702K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2DPS2000-04-07
266131769681702K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2DPS2000-04-07
266071078857097K993090SILHOUETTE FCKPR1999-10-01
266131982065109K992929DASH 3000 PATIENT MONITORMHX1999-11-26
266131592364386K992637MUSE CARDIOVASCULAR INFORMATION SYSTEMDSI1999-11-03
2392561234491200K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTIONDPS1999-11-18
266131234491200K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTIONDPS1999-11-18
2392562061004286K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHSLOS1999-08-19
266132061004286K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHSLOS1999-08-19
266131159760168K991014CASE 8000 EXERCISE TESTING SYSTEMLOS1999-10-20
266131726057925K990068SOLAR 9500 INFORMATION MONITORMHX1999-07-14
266032055471170K982267DPX-RX BONE DENSITOMETERKGI1998-08-18
266612055471170K982267DPX-RX BONE DENSITOMETERKGI1998-08-18
266071143597490K982196DIGITAL RADIOGRAPHIC IMAGING SYSTEMKPR1998-10-06
266061518399848K981190HIGH IMPEDANCE CARDIAC GATING CABLELNH1998-06-30
266131228838019K980495MUSE CARDIOVASCULAR INFORMATION SYSTEMLOS1998-05-07
266131387577031K973984RAC 2A MODULE HOUSINGCCK1998-01-16
266131018349888K973403CARDIOSMART STLOS1998-03-12
266071199830541K973168SMARTVIEW OPTIONS FOR HISPEED CT/IJAK1997-11-21
266071712025503K973039LEGACY/LEGACY-D TABLEIXR1997-10-16
266061197037114K971667CARDIAC PHASED ARRAY COILMOS1997-07-23
266071310249920K964746HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTIONJAK1997-01-24
266061805200714K962061MAGNETIC RESONANCE DIAGNOSTIC SYSTEMLNH1996-11-27
266071647162663K960265ADVANTAGE WINDOWS WITH FUNCTOOL OPTIONLLZ1996-07-03
266061647162663K960265ADVANTAGE WINDOWS WITH FUNCTOOL OPTIONLLZ1996-07-03
266061303578194K953595MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYMOS1995-10-27
266131138611812K952474EAGLE 3000 PATIENT MONITORDRT1995-10-19
266071017157219K950317ADVANTX 1824 SPOTFILM DEVICEIXL1995-02-08
266071336178899K944967TOMO-LINKIZF1994-12-09
266071065452841K943805PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHDJAA1994-09-23
266071951622246K936180TC+ SYSTEM (TILTING C-ARM SYSTEM)OWB1994-03-16
266071457478268K924310PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPICLLZ1993-01-21
266071324907077K923309ARGUS PET SYSTEMKPS1992-09-29
266061808495795K923264GENERAL PURPOSE FLEX COILLNH1992-09-30
266131204645821K921669MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITIONLOS1993-05-07
266131793768138K920790MARQUETTE EAGLE MONITORDSI1994-04-19
266131522902795K915073MARQUETTE SV O2 MODULEDQE1992-12-29
266131033504375K912799EAGLE SYSTEMLMC1991-12-18
266061590389999K911806MAGNETIC RESONANCE DIAGNOSTIC ACCESSORYLNH1991-06-28
266071423501434K910902VMX MOBILE X-RAY SYSTEMIZL1991-09-09
2392561733488856K910307CARDIOLAB AMPLIFIER MODULE (CAM)DRR1991-04-12
266131733488856K910307CARDIOLAB AMPLIFIER MODULE (CAM)DRR1991-04-12
266131516301403K904863MGA-IR SIDESTREAM PCO2 MODULECCK1991-06-19
266071634715199K902989G.E. MONITROL 90 AND G.E. MONITROL 15IXR1990-10-29
266131580261646K900598TRAMSCOPE SYSTEMDPS1990-04-26
266131837650427K900540TRAM PATIENT MONITORDSI1990-07-17
266071033308024K894142ULTRANET-S COLLIMATORIZW1989-11-06
266071153696947K884930COMPAX MODEL 40, 400, 400TIZZ1988-12-22
266132027238332K874327SKIN PREP ANALYZERKRC1987-11-23
266611592831778K873296DPX BONE DENSITOMETERKGI1988-06-06
266071913035631K862120SCX SYSTEMJAA1986-06-16
266071904882389K843926PRESTILIX 1690IXR1984-12-17
266131331577831K840932MUSE-DPDXN1984-10-30
266071667251860K827928VRT TABLEIZZ1982-09-29
266071547305233K802047AMX-IIIIZL1980-10-23
266071649810769K801320SFX-90 TABLE/SPOTFILMER W/FLUORICON L200JAA1980-07-21
266072013638259K760466TABLE, X-RAY, RFX CLASSICALIXR1976-08-26
266241228006311K260673LOGIQ 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
3299151405156630K254161Automated Aortic Stenosis Software (AutoAS)POK2026-03-27
266061062007915K253780SIGNA™ BoltLNH2026-02-06
266071012066396K253520Photonova Spectra, Photonova Spectra SelectJAK2026-03-20
266071480009403K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH2026-04-14
266031480009403K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH2026-04-14
266241695495357K253370LOGIQ TotusIYN2026-01-08
266241684322365K253366LOGIQ FortisIYN2026-01-07
266061186493886K252379AIR Recon DLLNH2025-12-23
266241111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
3299152053695773K251985LOGIQ E10IYN2025-10-29
844812053695773K251985LOGIQ E10IYN2025-10-29
266242053695773K251985LOGIQ E10IYN2025-10-29
844811078030117K251963LOGIQ E10sIYN2025-10-29
266241078030117K251963LOGIQ E10sIYN2025-10-29
3330421015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
2392561015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
266241015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
3299151846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
844811846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266241846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266241040314840K251169Vivid PioneerIYN2025-07-10
266071652607470K250941Revolution VibeJAK2025-08-01
266031110546406K250788Definium Tempo SelectKPR2025-08-28
266241833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
266061589397737K243667Sonic DLLNH2025-06-05
844811273874788K243628Vivid T9/Vivid T8IYN2025-02-11
266241273874788K243628Vivid T9/Vivid T8IYN2025-02-11
844811905736941K243620Vivid iqIYN2025-02-11
266241905736941K243620Vivid iqIYN2025-02-11
3330421816403130K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)DQK2024-12-12
266271816403130K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)DQK2024-12-12
3299151586260182K243065Cardiac GuidanceQJU2025-01-15
266032046382696K242678Definium Pace Select ETKPR2024-10-01
3330421257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
2392561257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
266271257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
266241257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
266241519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
844811519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
266241955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
266071201360968K241665Omni LegendKPS2024-08-08
3299151369655905K240206Venue SprintIYN2024-06-10
266241369655905K240206Venue SprintIYN2024-06-10
844811829127751K240111VenueIYN2024-06-10
3299151829127751K240111VenueIYN2024-06-10
266241829127751K240111VenueIYN2024-06-10
844811060568579K240053Venue GoIYN2024-06-10
266241060568579K240053Venue GoIYN2024-06-10
3299151060568579K240053Venue GoIYN2024-06-10
266272034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
3330422034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
2392562034590375K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OMWI2024-03-20
266241574908925K234106Venue FitIYN2024-06-10
3299151574908925K234106Venue FitIYN2024-06-10
844811574908925K234106Venue FitIYN2024-06-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYN2812026-03-24
MHX772025-07-09
LNH762026-02-06
DQK502024-12-12
JAK462026-03-20
DPS392026-01-26
MWI212024-04-25
KPS202024-08-08
KGI132019-09-19
KPR122025-08-28
IZL112021-04-28
IYO102012-04-19
DSI92007-03-16
LLZ82018-05-04
MOS82011-04-01
DXJ62016-09-15
DXQ62013-04-09
LOS61999-10-20
QIH52026-04-14
HGM52022-06-23
OUO52022-01-20
JAA52008-06-11
DQA42010-03-12
IXR41997-10-16
BSZ32023-03-28
CBK32021-11-04
FMZ32016-03-17
PAA32012-09-18
DRT32006-08-04
QJU22025-01-15
QBS22023-05-25
QFM22019-08-12
IZF22013-11-18
MUA22013-02-25
ITX22012-08-17
CCK21998-01-16
DRR21991-04-12
IZZ21988-12-22
POK12026-03-27
QKB12023-05-04

PMA

PMN

Vivid Iq

2022-07-18

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Venue

2022-06-27

GE Medical Systems

Venue Go

2022-06-21

GE Medical Systems Ultrasound And Primary Care Diagnostics

AIR Recon DL

2022-06-08

GE Medical Systems,LLC (GE Healthcare)

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,

PET VCAR

2021-07-27

GE Medical Systems SCS

MaxFOV 2

2021-03-02

GE Medical Systems, LLC.

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,

Graffiti

2020-12-08

GE Medical Systems Information Technologies, Inc.

Vscan Air

2020-11-20

GE Medical Systems Ultrasound And Primary Care Diagnostics,

Venue Go

2020-11-18

GE Medical Systems Ultrasound And Primary Care Diagnostics,

Venue

2020-11-13

GE Medical Systems Ultrasound And Primary Care Diagnostics,

200 records. Showing 1-40. Next

GUDID

MAC

2026-01-27

Ge Medical Systems Information Technologies, Inc.

Allia

2025-12-17

GE MEDICAL SYSTEMS

Portrait CVAXB

2025-12-10

Ge Medical Systems Information Technologies, Inc.

Portrait CSSXB

2025-12-10

Ge Medical Systems Information Technologies, Inc.

LOGIQ

2025-12-05

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

LOGIQ

2025-12-05

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

LOGIQ

2025-12-05

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

LOGIQ

2025-12-05

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

LOGIQ

2025-12-05

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue Go

2025-11-17

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue Fit

2025-11-17

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue

2025-11-17

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

NA

2025-09-26

GE Medical Systems (Tianjin) Co., Ltd.

Caption

2025-09-15

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue Sprint

2025-07-31

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue Go

2025-07-31

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue Fit

2025-07-31

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Venue

2025-07-31

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Caption

2025-07-28

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

CARESCAPE

2025-06-04

Ge Medical Systems Information Technologies, Inc.

MLCL Upgrade

2025-05-05

Ge Medical Systems Information Technologies, Inc.

Mac-Lab

2025-05-05

Ge Medical Systems Information Technologies, Inc.

ComboLab

2025-05-05

Ge Medical Systems Information Technologies, Inc.

CardioLab

2025-05-05

Ge Medical Systems Information Technologies, Inc.

NA

2025-05-01

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

NA

2025-04-15

GE Medical Systems (Tianjin) Co., Ltd.

CAM

2025-04-07

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

CAM

2025-04-07

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

CASE

2025-03-25

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

CASE

2025-03-25

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

CardioSoft

2025-03-25

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

200 records. Showing 1-40. Next