BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Genius Digital Diagnostics System with the Genius Cervical AI algorithm

    Reg #: 3006330030 · FEI: 3006330030 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hologic, Inc.
    Registration Number
    3006330030
    FEI Number
    3006330030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    445 Simarano Drive
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN210035

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm QYV

    Proprietary Names

    Genius Digital Diagnostics System with the Genius Cervical AI algorithm

    Establishment Types

    Manufacture Medical Device