BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P140011 · Supplement: S003 · Decision Mar 23, 2017
    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
    S003
    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, 2017
    Date Received
    August 26, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    The device, as modified, will be marketed under the trade name Mammomat Inspiration With Tomosynthesis Option and is indicated for use with the EMPIRE reconstruction algorithm for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer.A screening exam may consist of a:- 2D image set.- 3D DBT image set and a 2D FFDM image set or a- 3D DBT image set alone.

    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