BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Volume Viewer MR

    Reg #: 2126677 · FEI: 2126677 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS, LLC
    Registration Number
    2126677
    FEI Number
    2126677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3000 N GRANDVIEW BLVD.
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041521

    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
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    Volume Viewer MR Volume Viewer Apps Volume Viewer 4 Volume Viewer 2 Volume Viewer 3.1 Volume Viewer 5 Autolaunch Volume Viewer PET Volume Viewer Volume Viewer Innova PROView Preprocessing Enabler Reporting Tool OncoQuant Volume Illumination Volume Viewer Innova Enhanced HAV Volume Viewer Innova 3DStent Head Auto Views

    Establishment Types

    Manufacture Medical Device