BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Genius AI Detection 2.0

    K Number: K243341 · Decision Jul 31, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    116
    Review Days
    279

    Basic Information

    Device Name
    Genius AI Detection 2.0
    K Number
    K243341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hologic, Inc.
    Date Received
    October 25, 2024
    Decision Date
    July 31, 2025
    Product Code
    QDQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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