BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FX

    Reg #: 3014661828 · FEI: 3014661828 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IMAGEN TECHNOLOGIES, INC.
    Registration Number
    3014661828
    FEI Number
    3014661828
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    420 Lexington Avenue, Suite 300, Office 365
    City
    New York
    State
    NY
    ZIP
    10170
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193417

    Owner / Operator

    Firm Name
    Imagen Technologies, Inc.
    Operator Number
    10057966
    Address
    224 W 35th Street, Suite 500
    City
    New York
    State
    NY
    Postal Code
    10001
    Country
    US
    Correspondent
    Sarah Gourgoulianis

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS

    Proprietary Names

    FX FractureDetect

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198