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

    Allix5

    K Number: DEN240047 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Allix5
    K Number
    DEN240047
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.8500
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Clairity, Inc.
    Date Received
    September 6, 2024
    Decision Date
    May 30, 2025
    Product Code
    SEZ
    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
    SEZ Radiological Software Device To Predict Future Breast Cancer Risk