BEUDAMED
    FDA Registration Active 🇫🇷 France

    BrainWave Struct Reporting

    Reg #: 9611343 · FEI: 1000284313 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS SCS
    Registration Number
    9611343
    FEI Number
    1000284313
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    283 RUE DE LA MINIERE
    City
    BUC Yvelines
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K033867

    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

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    BrainWave Struct Reporting BrainWave Performance BrainWave Post Acquisition (PA) BrainWave Adv Visualization Brainwave PA Performance BrainWave Adv DTI Tracking BrainWave Fusion Perf Brainwave PA Fusion Performance BrainWave BrainWave Tract Generation Brainwave PA Brainwave Resting State BrainWave Skull Stripping

    Establishment Types

    Manufacture Medical Device