BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ProFound Detection (V4)

    Reg #: 3026970882 · FEI: 3026970882 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICAD INC.
    Registration Number
    3026970882
    FEI Number
    3026970882
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Townsend West, Suite 6
    City
    Nashua
    State
    NH
    ZIP
    03063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240417

    Owner / Operator

    Firm Name
    iCAD INC.
    Operator Number
    9054868
    Address
    2 Townsend West, Suite 6, --
    City
    Nashua
    State
    NH
    Postal Code
    03063
    Country
    US
    Correspondent
    Melanie Leibowitz

    Products

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

    Proprietary Names

    ProFound Detection (V4)

    Establishment Types

    Manufacture Medical Device