BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P140011 · Decision Apr 21, 2015
    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
    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
    April 21, 2015
    Date Received
    June 26, 2014
    Expedited Review
    N
    Docket Number
    15M-1460

    Advisory Committee Statement

    APPROVAL FOR THE MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D AS WELL AS 3D DIGITAL MAMMOGRAPHY IMAGES TO BE USED IN SCREENING AND DIAGNOSIS OF BREAST CANCER. EACH SCREENING EXAMINATION MAY CONSIST OF CC AND MLO VIEWS IN: A 2D IMAGE SET, OR A 2D AND 3D IMAGE SET. NOTE: THE SCREENING EXAMINATION MAY CONSIST OF 2D FFDM IMAGES SET WITH OR WITHOUT THE 3D 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