BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Full Field Digital, System, X-Ray, Mammographic

    PMA: P010017 · Decision Sep 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40

    Basic Information

    Device Name
    Full Field Digital, System, X-Ray, Mammographic
    Trade Name
    SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
    PMA Number
    P010017
    Device Class
    FDA Class 2
    Product Code
    MUE
    Generic Name
    Full field digital, system, x-ray, mammographic
    Regulation Number
    892.1715
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 25, 2001
    Date Received
    March 13, 2001
    Expedited Review
    N
    Docket Number
    01M-0509

    Advisory Committee Statement

    APPROVAL FOR THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE IS A DEDICATED MAMMOGRAPHY SYSTEM INTENDED TO PRODUCE RADIOGRAPHIC IMAGES OF THE HUMAN BREAST FOR THE PURPOSE OF DIAGNOSTIC AND SCREENING MAMMOGRAPHY. THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHY SYSTEMS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUE Full Field Digital, System, X-Ray, Mammographic