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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16511043002737156GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES1Y2026-01-01465 PAN AMERICAN DR STE 11 EL PASO TX US 79907

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266271379081908K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2026-07-24
266271816403130K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)DQK2024-12-12
266271257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
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
266271182464020K233810Portrait VSMMWI2024-04-25
266271743458197K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK2023-12-13
266271175583964K230626Portrait™ 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
266271423213164K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)MHX2023-04-06
266271307109943K221904EK12 V2 AlgorithmMHX2022-12-20
266271152466224K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiXDQK2022-02-17
266271771137171K213363CARESCAPE B450, E-musbMHX2022-04-13
266271481395238K213234CARESCAPE 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
266271513812715K213181CARESCAPE B650, E-musbMHX2022-04-13
266271244894438K173830MAC VU360 Resting ECG Analysis SystemDPS2018-09-18
266271141593193K170155EK12 AlgorithmMHX2017-06-06
266271610211832K162012CARESCAPE Central Station V2DXJ2016-09-15
266272055910021K152993MUSE Cardiology Information SystemDQK2016-01-12
266271914335518K132437MARS HOLTER ANALYSIS WORKSTATIONDQK2013-12-04
266271437664524K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYSDQK2013-05-01
266271641012335K130155MUSE CARDIOLOGY INFORMATION SYSTEMDQK2013-03-01
266271480888881K111200MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEMDQK2011-10-12
266271034492113K110266MAC 5500 HD, MAC 3500DPS2011-04-29
266271749049129K110132MUSE CARDIOLOGY INFORMATION SYSTEMDQK2011-05-25
266271687408750K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQK2011-02-16
266271027797744K102426CARESCAPE MODEL V100 VITAL SIGNS MONITORMWI2010-10-20
266271730527546K093141MARS HOLTER ANALYSIS WORKSTATIONDQK2009-12-29
266271914683961K081437MAC 1600 ECG ANALYSIS SYSTEMDPS2008-07-15
266271478915015K080251APEXPRO TELEMETRY SYSTEMSMHX2008-06-20
266271765844170K073625MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEMDPS2008-01-25
266271356856513K073462MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIESMHX2008-01-11
266271211042766K073203CARESCAPE V100MHX2007-11-29
266271295973009K071073SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEMHX2007-05-11
266271619878410K053121TRAM MODULEMHX2006-04-05
266271371159883K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500DPZ2004-09-02
266271572004204K031561CARDIOSOFT/CASE CARDIAC TESTING SYSTEMDQK2003-08-01
266271773827373K001688DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETERDQA2000-06-30
266271766502212

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX132026-07-24
DQK122024-12-12
MWI42024-04-25
DPS42018-09-18
DXJ12016-09-15
DPZ12004-09-02
DQA12000-06-30

PMA#

PMN#

135 records. Showing 1-40. Next