BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PowerLook Breast Assessment v3.4

    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
    K180125

    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
    System, Image Processing, Radiological LLZ

    Proprietary Names

    PowerLook Breast Assessment v3.4

    Establishment Types

    Manufacture Medical Device