BEUDAMED
    Product Code: SEZ FDA class 2 21 CFR 892.8500

    Radiological Software Device To Predict Future Breast Cancer Risk

    Radiology

    A radiological software device to predict future breast cancer risk is a radiology software device that analyzes breast imaging radiological images and/or derived inputs to provide qualified healthcare professionals with a numeric probability and/or risk category indicating the patient's future (incident) breast cancer risk from the time the analyzed images were acquired; it is not intended to diagnose, detect, or inform the treatment of existing cancer. It is classified as FDA Class II (510(k) required) under regulation 892.8500 in the Radiology specialty, with product code SEZ. The device is not an implant and does not support life-sustaining functions.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    SEZ
    Device Class
    FDA class 2
    Regulation Number
    892.8500
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patient’s future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN240047 Allix5

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.