GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES INC.
668 devices
Multi-jurisdiction products
The same product registered across multiple national regulators, grouped so you can see its full clearance coverage at a glance.
- ALGORITHM SERVICES2 cert. types · 2 registered devices
- MLCL Client Software AltiX AI.i2 cert. types · 2 registered devices
- Mac-Lab AltiX AI.i2 cert. types · 2 registered devices
- CardioLab AltiX AI.i2 cert. types · 2 registered devices
- ComboLab AltiX AI.i2 cert. types · 2 registered devices
- Portrait Core Services CSSXB2 cert. types · 2 registered devices
- B1X5-F2 Second Frame2 cert. types · 2 registered devices
Products
- PATIENT MONITORPatient MonitoringHealth Canada
- Mac-LabOtherFDA 510(k)
- MAC 7 Resting ECG Analysis SystemCardiologyFDA 510(k)CE-MDR
- CAREINTELLECT PERINATALOtherHealth Canada
- Portrait CSSXBOtherFDA 510(k)
- CareIntellect PerinatalOtherFDA 510(k)
- CLAB ECG TRUNK CABLEOtherHealth Canada
- CARDIOLAB SYSTEM - ACQUISITION UPGRADE CLABIIPLUS AMPLIFIERIPLHealth Canada
- MAC-LAB ALTIXOtherHealth Canada
- Portrait VSM Vital Signs MonitorPatient MonitoringANVISA
- MAC 7 RESTING ECG ANALYSIS SYSTEMOtherHealth Canada
- Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125POtherFDA 510(k)
- CardioLabOtherFDA 510(k)
- ComboLabOtherFDA 510(k)
- MLCL Client SoftwareOtherFDA 510(k)
- Mural Clinical ViewerOtherFDA 510(k)
- Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)OtherFDA 510(k)
- GE Cardiosoft V7.0 Cardiac Testing SystemOtherHSA
- PORTRAIT CAU01OtherHealth Canada
- PORTRAIT VSMOtherHealth Canada
- MURAL PERINATAL SURVEILLANCEOtherFDA 510(k)
- Portrait VSMOtherFDA 510(k)
- Portrait 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 OOtherFDA 510(k)
- CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemOtherFDA 510(k)
- Portrait CAU01Patient MonitoringFDA 510(k)
- CARESCAPE TELEMETRY SERVER ARK-2250LOtherHealth Canada
- Portrait 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), PortraitOtherFDA 510(k)
- Sistema de Análise de ECG em Repouso MAC 5OtherANVISA
- ONE-CUFOtherFDA 510(k)
- EK12 ECG ALGORITHMOtherHealth Canada
- ALGORITHM SERVICESOtherFDA 510(k)
- MURAL PERINATAL SURVEILLANCEOtherHealth Canada
- EK12 V2 AlgorithmOtherFDA 510(k)
- GE ComboLabOtherHSA
- MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis SystemCardiologyFDA 510(k)
- MAC 5 A4OtherHealth Canada
- Mural Perinatal SurveillanceOtherFDA 510(k)
- CENTRICITY PERINATALOtherFDA 510(k)
- CAM CONNECT 14OtherHealth Canada
- MLCL CablesOtherFDA 510(k)
- CARESCAPE 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 MKS201OtherFDA 510(k)
- Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125POtherFDA 510(k)
- GE MAC 5 Resting ECG Analysis SystemOtherHSA
- MAC 7 - Resting ECG Analysis SystemCardiologyFDA 510(k)
- ECG LEADWIRE SETOtherHealth Canada
- 심전도분석소프트웨어OtherMFDS
- ECG CABLEOtherHealth Canada
- GraffitiOtherFDA 510(k)
- ASSY SECOND FRAMEOtherFDA 510(k)
- Monitor B125, Monitor B105OtherFDA 510(k)
- CARESCAPE ECGOtherFDA 510(k)CE-MDR
- CARESCAPE PRESSUREOtherFDA 510(k)CE-MDR
- CARESCAPE TEMPERATUREOtherFDA 510(k)CE-MDR
- Família de Monitores Carescape OneOtherANVISA
- GE MUSE™ NX Cardiology Information SystemOtherHSA
- CARESCAPE ECG NEONATAL INTENSIVE CARE (NICU) TRUNK CABLERehabilitationHealth Canada
- GE ApexPro Telemetry SystemPatient MonitoringHSA
- CentricityOtherFDA 510(k)
- MAC VU360 Resting ECG Analysis SystemCardiologyFDA 510(k)
- MAC VU360OtherHealth Canada
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