BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P080003 · Supplement: S006 · Decision Mar 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    Selenia Dimensions/3Dimensions 3D System
    PMA Number
    P080003
    Supplement Number
    S006
    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
    March 23, 2018
    Date Received
    September 15, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to the Selenia Dimensions/3Dimensions 3D System with 15 projection angles for approval of the high resolution tomosynthesis and synthesized 2D feature, SmartCurve compression paddles, as well as a new linear grid for the Full-field Digital Mammography System.

    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