BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P080003 · Supplement: S008 · Decision Oct 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    Selenia Dimensions 3D System High Resolution Tomosynthesis
    PMA Number
    P080003
    Supplement Number
    S008
    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
    October 24, 2019
    Date Received
    April 4, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software option 3DQuoromTM technology, which generates thicker 6 mm slices (also referred as SmartSlices or slabs) and change to the indications for use statement as a result of this update.

    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