BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P140011 · Supplement: S001 · Decision May 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
    PMA Number
    P140011
    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 12, 2016
    Date Received
    November 23, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change to the indications for use statement. The device, as modified, will be marketed under the trade name MAMMOMAT Inspiration with Tomosynthesis Option and is indicated for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3D DBT image set and/or a 2D FFDM image set.

    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