BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Saige-Dx

    Reg #: 3018733944 · FEI: 3018733944 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DEEPHEALTH
    Registration Number
    3018733944
    FEI Number
    3018733944
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    212 Elm St.
    City
    Somerville
    State
    MA
    ZIP
    02144
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241747

    Owner / Operator

    Firm Name
    DeepHealth
    Operator Number
    10081546
    Address
    212 Elm St.
    City
    Somerville
    State
    MA
    Postal Code
    02144
    Country
    US

    Products

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

    Proprietary Names

    Saige-Dx SmartMammoDx

    Establishment Types

    Manufacture Medical Device