BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P080003 · Supplement: S001 · Decision May 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    SELENIA DIMENSIONS 3D SYSTEM
    PMA Number
    P080003
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    OTE
    Generic Name
    Digital breast tomosynthesis
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 16, 2013
    Date Received
    October 9, 2012
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    13M-0595

    Advisory Committee Statement

    APPROVAL FOR THE SELENIA DIMENSIONS 3D SYSTEM. THIS DEVICE IS INDICATED TO GENERATE DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SELENIA DIMENSIONS (2D OR 3D) SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS A 2D MAMMOGRAPHY SYSTEM FOR SCREENING MAMMOGRAMS. SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO GENERATE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS. EACH SCREENING EXAMINATION MAY CONSIST OF: A 2D FFDM IMAGE SET; OR A 2D AND 3D IMAGE SET, WHERE THE 2D IMAGE CAN BE EITHER A FFDM OR A 2D IMAGE GENERATED FROM THE 3D IMAGE SET. THE SELENIA DIMENSIONS SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.

    Classifications

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

    Product Code Device Name
    OTE Digital Breast Tomosynthesis