BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P080003 · Supplement: S005 · Decision May 23, 2017
    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
    S005
    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 23, 2017
    Date Received
    May 2, 2017
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the Physician Labeling of the Selenia Dimensions 3D System and the Selenia Dimensions 3D System with C-View Software Module, to claim superior screening accuracy of 3D plus 2D imaging, where the 2D image can be either a synthesized 2D or a Full Field Digital Mammography (FFDM) image, as compared to FFDM alone, for women with dense breasts.

    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