BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prodigy Primo

    Reg #: 2183066 · FEI: 2183066 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
    Registration Number
    2183066
    FEI Number
    2183066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3030 Ohmeda Drive
    City
    MADISON
    State
    WI
    ZIP
    53718
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191112

    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
    Densitometer, Bone KGI

    Proprietary Names

    Prodigy Primo GEHC DXA Bone Densitometers with enCORE version 18 Prodigy Primo Compact Prodigy Prodigy Pro Prodigy Advance Lunar iDXA Prodigy Pro Compact

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility