FDA.report

GE Medical Systems Information Technologies, Inc.

Matched from indexed company URL: Ge Medical Systems Information Technologies, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30015702353001570235GE Medical Systems Information Technologies, Inc.1N2026-01-013114 N Grandview Blvd Waukesha WI US 53188
30123598773012359877GE Medical Systems Information Technologies, Inc.1N2026-01-019900 Innovation Drive Wauwatosa WI US 53226
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
266131203649944K993757SOLAR 7/8000DSI2000-03-23
266131769681702K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2DPS2000-04-07
2392561769681702K993414PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2DPS2000-04-07
266131982065109K992929DASH 3000 PATIENT MONITORMHX1999-11-26
266131592364386K992637MUSE CARDIOVASCULAR INFORMATION SYSTEMDSI1999-11-03
266131234491200K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTIONDPS1999-11-18
2392561234491200K991786MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTIONDPS1999-11-18
266132061004286K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHSLOS1999-08-19
2392562061004286K991735MAC 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
266131228838019K980495MUSE CARDIOVASCULAR INFORMATION SYSTEMLOS1998-05-07
266131387577031K973984RAC 2A MODULE HOUSINGCCK1998-01-16
266131018349888K973403CARDIOSMART STLOS1998-03-12
266131138611812K952474EAGLE 3000 PATIENT MONITORDRT1995-10-19
266131204645821K921669MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITIONLOS1993-05-07
266131793768138K920790MARQUETTE EAGLE MONITORDSI1994-04-19
266131522902795K915073MARQUETTE SV O2 MODULEDQE1992-12-29
266131033504375K912799EAGLE SYSTEMLMC1991-12-18
266131733488856K910307CARDIOLAB AMPLIFIER MODULE (CAM)DRR1991-04-12
2392561733488856K910307CARDIOLAB AMPLIFIER MODULE (CAM)DRR1991-04-12
266131516301403K904863MGA-IR SIDESTREAM PCO2 MODULECCK1991-06-19
266131580261646K900598TRAMSCOPE SYSTEMDPS1990-04-26
266131837650427K900540TRAM PATIENT MONITORDSI1990-07-17
266132027238332K874327SKIN PREP ANALYZERKRC1987-11-23
266131331577831K840932MUSE-DPDXN1984-10-30
2392561015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
3330421015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
3330421816403130K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)DQK2024-12-12
2392561257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
3330421257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
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
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
2392561182464020K233810Portrait VSMMWI2024-04-25
3330421182464020K233810Portrait VSMMWI2024-04-25
2392561743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
3330421743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
2392561175583964K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™MWI2023-08-11
3330421279198482K222586Mural Clinical ViewerMHX2022-12-21
2392561307109943K221904EK12 V2 AlgorithmMHX2022-12-20
3330421307109943K221904EK12 V2 AlgorithmMHX2022-12-20
2392561402586086K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemDPS2022-10-18
3330421402586086K221321MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemDPS2022-10-18
2392561967980478K220732Mural Perinatal SurveillanceHGM2022-06-23
3330421967980478K220732Mural Perinatal SurveillanceHGM2022-06-23
2392561152466224K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXDQK2022-02-17
3330421152466224K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXDQK2022-02-17
2392562048838415K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PMHX2022-04-01
3330422048838415K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PMHX2022-04-01
2392561481395238K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHX2022-04-12
3330421481395238K213234CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201MHX2022-04-12
2392561250802707K203786MAC 7 - Resting ECG Analysis SystemDPS2021-04-30
266131540286742K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESMHX2020-03-29
2392561540286742K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESMHX2020-03-29
3330421540286742K200494CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRESMHX2020-03-29
266131324799321K183116Unity Network IDMWI2018-12-06
266131244894438K173830MAC VU360 Resting ECG Analysis SystemDPS2018-09-18
2392561244894438K173830MAC VU360 Resting ECG Analysis SystemDPS2018-09-18
266131550674428K171580Monitor B125, Monitor B105MHX2017-11-01
266131943400970K170199Unity Network IDMWI2017-05-12
266131141593193K170155EK12 AlgorithmMHX2017-06-06
2392561141593193K170155EK12 AlgorithmMHX2017-06-06
266131610211832K162012CARESCAPE Central Station V2DXJ2016-09-15
2392561610211832K162012CARESCAPE Central Station V2DXJ2016-09-15
3330421610211832K162012CARESCAPE Central Station V2DXJ2016-09-15
266132055910021K152993MUSE Cardiology Information SystemDQK2016-01-12
2392562055910021K152993MUSE Cardiology Information SystemDQK2016-01-12
3330422055910021K152993MUSE Cardiology Information SystemDQK2016-01-12
266131862447666K151063Monitor B40MHX2015-12-15
266131533683446K142840Unity Network IDMWI2015-01-07
266131319222028K142288MAC 800 Resting ECG Analysis SystemDPS2014-12-03
266131729612319K14196312SL ECG ANALYSIS PROGRAMMHX2015-02-05
2392561729612319K14196312SL ECG ANALYSIS PROGRAMMHX2015-02-05
266131552090501K133882CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)DXJ2014-04-30
266131739806059K133622MAC 2000 ECG ANALYSIS SYSTEMDPS2014-01-23
2392561739806059K133622MAC 2000 ECG ANALYSIS SYSTEMDPS2014-01-23
266131389359552K133576MONITOR B40MHX2014-02-21
266131914335518K132437MARS HOLTER ANALYSIS WORKSTATIONDQK2013-12-04
2392561914335518K132437MARS HOLTER ANALYSIS WORKSTATIONDQK2013-12-04
266131437664524K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYSDQK2013-05-01
2392561437664524K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYSDQK2013-05-01
266131028121400K130584MONITOR B40MHX2013-06-26
266131641012335K130155MUSE CARDIOLOGY INFORMATION SYSTEMDQK2013-03-01
2392561641012335K130155MUSE CARDIOLOGY INFORMATION SYSTEMDQK2013-03-01
266131916573876K123996RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFFDXQ2013-04-09
2392561916573876K123996RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFFDXQ2013-04-09
3330421916573876K123996RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFFDXQ2013-04-09
266131707624037K122253PROCARE MONITOR B20MHX2013-03-22
266131651641171K120770QT GUARD PLUS ANALYSIS SYSTEMDPS2012-12-06
2392561651641171K120770QT GUARD PLUS ANALYSIS SYSTEMDPS2012-12-06
266131465883490K120598PROCARE MONITOR B40MHX2012-07-19
266131874094686K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFDXQ2012-10-03
2392561874094686K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFDXQ2012-10-03
3330421874094686K120125SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUFDXQ2012-10-03
3330421604563987K111614CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CAREHGM2011-09-26
266131480888881K111200MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEMDQK2011-10-12
2392561480888881K111200MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEMDQK2011-10-12
266131034492113K110266MAC 5500 HD, MAC 3500DPS2011-04-29
2392561034492113K110266MAC 5500 HD, MAC 3500DPS2011-04-29
3330421034492113K110266MAC 5500 HD, MAC 3500DPS2011-04-29
266131749049129K110132MUSE CARDIOLOGY INFORMATION SYSTEMDQK2011-05-25
2392561749049129K110132MUSE CARDIOLOGY INFORMATION SYSTEMDQK2011-05-25
266131318534575K103765MAC 600 RESTING ECG ANALYSIS SYSTEMDPS2011-05-17
2392561318534575K103765MAC 600 RESTING ECG ANALYSIS SYSTEMDPS2011-05-17
266131687408750K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQK2011-02-16
2392561687408750K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQK2011-02-16
266131995221237K103432UNITY NETWORK IDMWI2010-12-17
266131027797744K102426CARESCAPE MODEL V100 VITAL SIGNS MONITORMWI2010-10-20
3330421027797744K102426CARESCAPE MODEL V100 VITAL SIGNS MONITORMWI2010-10-20
266131730527546K093141MARS HOLTER ANALYSIS WORKSTATIONDQK2009-12-29
2392561730527546K093141MARS HOLTER ANALYSIS WORKSTATIONDQK2009-12-29
2392561213573859K09236912SL ECG ANALYSIS PROGRAMMHX2010-02-24
266131157184506K092027CARESCAPE MONITOR B850MHX2009-08-28
2392561983652741K091594HEART-EXERCISEMHX2009-07-29
266131220360464K090702MODIFICATION TO DASH 2500 PATIENT MONITORMHX2009-04-15
266131282964752K090212MAC 800 RESTING ECG ANALYSIS SYSTEMDPS2009-02-19
266131091468499K083750CAPNOSTAT / CAPNOFLEX CO2 SYSTEMMHX2009-03-23
266131181447889K083639MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWAREDQK2009-02-17
2392561181447889K083639MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWAREDQK2009-02-17
266131914683961K081437MAC 1600 ECG ANALYSIS SYSTEMDPS2008-07-15

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MHX522025-07-09
DQK382024-12-12
DPS292026-01-26
MWI162024-04-25
DSI92007-03-16
DXQ62013-04-09
LOS61999-10-20
DXJ52016-09-15
HGM42022-06-23
DRT32006-08-04
DQA22006-05-22
CCK21998-01-16
DRR21991-04-12
CBK12008-05-30
MSX12002-03-20
OLW12001-10-01
DSB12001-04-09
DQE11992-12-29
LMC11991-12-18
KRC11987-11-23
DXN11984-10-30

PMA

PMN

Graffiti

2020-12-08

GE Medical Systems Information Technologies, Inc.

EK12 Algorithm

2017-06-06

GE Medical Systems Information Technologies, Inc.

Applications

GUDID

MAC

2026-01-27

Ge Medical Systems Information Technologies, Inc.

Portrait CSSXB

2025-12-10

Ge Medical Systems Information Technologies, Inc.

Portrait CVAXB

2025-12-10

Ge Medical Systems Information Technologies, Inc.

CARESCAPE

2025-06-04

Ge Medical Systems Information Technologies, Inc.

MLCL Upgrade

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.

Mac-Lab

2025-05-05

Ge Medical Systems Information Technologies, Inc.

NA

2025-05-01

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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.

MAC

2025-03-13

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.