BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Transpara 1.7.y

    Reg #: 3030412475 · FEI: 3030412475 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ScreenPoint Medical, Inc.
    Registration Number
    3030412475
    FEI Number
    3030412475
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8 The Green, Suite B
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210404

    Owner / Operator

    Firm Name
    ScreenPoint Medical
    Operator Number
    10059521
    Address
    Mercator II, 7th floor, Toernooiveld 300
    City
    Nijmegen
    State
    Gelderland
    Postal Code
    6525 EC
    Country
    NL

    Products

    Device Name Product Code
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ

    Proprietary Names

    Transpara 1.7.y

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198