BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

    Reg #: 1651104 · FEI: 3002737156 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    129
    Establishment Types
    2
    Classifications
    39

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Registration Number
    1651104
    FEI Number
    3002737156
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    465 PAN AMERICAN DR STE 11
    City
    EL PASO
    State
    TX
    ZIP
    79907
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223531

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Computer, Diagnostic, Programmable DQK
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Electrocardiograph DPS
    Stimulator, Nerve, Peripheral, Electric KOI
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Oximeter DQA
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Burst Suppression Detection Software For Electroencephalograph ORT
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Breathing Frequency BZQ
    Detector And Alarm, Arrhythmia DSI
    Cerebral Oximeter QEM
    Stimulator, Auditory, Evoked Response GWJ
    Alarm, Blood-Pressure DSJ
    Computer, Oxygen-Uptake BZL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Computer, Blood-Pressure DSK
    Oximeter, Ear DPZ
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Probe, Thermodilution KRB
    Oximeter, Tissue Saturation MUD
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Network And Communication, Physiological Monitors MSX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Display, Cathode-Ray Tube, Medical DXJ

    Proprietary Names

    CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ Central Viewer Application (Portrait CVA01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Core Services (Portrait CSS01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables ComboLab AltiX AI.i MLCL Client Software AltiX AI.i CardioLab AltiX AI.i Mac-Lab AltiX AI.i APEXPRO RECEIVER SUBSYSTEM CARESCAPE TELEMETRY SYSTEM APEXPRO CH NONIN XPOD OXIMETER APEXPRO QUAD RECEIVER MODULE ApexPro Telemetry System CARESCAPE Telemetry Server CARESCAPE T4 Transmitter ApexPro CH Transmitter CARESCAPE Telemetry T4 Transmitter CARESCAPE T14 Transmitter ApexPro FH Transceiver ApexPro 400 MHz Receiver ApexPro 600 MHz Receiver CARESCAPE Telemetry Server V4 CARESCAPE TELEMETRY SERVER V4 UPGRADE eMUSE Cardiology Information System MUSE Cardiology Information System MUSE Cardiology Information System V9 MUSE MUSE v9 MUSE NX E-musb CARESCAPE B450 CARESCAPE RAD CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM EK12 V2 CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor MLCL Client SW AltiX CardioLab AltiX ComboLab AltiX Mac-Lab AltiX MLCL Upgrade BT21 SpecialsLab v6.9.6 R3 ComboLab v6.9.6 R3 CardioLab v7 ComboLab v7 CardioLab v6.9.6 R3 Mac-Lab v7 Mac-Lab v6.9.6 R3 CARESCAPE B650

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device