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

    ProFound AI Software V2.1

    K Number: K191994 · Decision Oct 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    14
    Review Days
    70

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    Basic Information

    Device Name
    ProFound AI Software V2.1
    K Number
    K191994
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icad, Inc.
    Date Received
    July 26, 2019
    Decision Date
    October 4, 2019
    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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