BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Disocvery PET/CT 610 Clarity

    Reg #: 2126677 · FEI: 2126677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    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
    K081496

    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, Tomography, Computed, Emission KPS

    Proprietary Names

    Disocvery PET/CT 610 Clarity Discovery PET/CT 690 Discovery PET/CT 600 Optima 560 / Discovery 690 Elite Optima PET/CT 560FX Discovery PET/CT 610 Optima PET/CT 560 Discovery PET/CT 710

    Establishment Types

    Manufacture Medical Device