BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P140011 · Supplement: S007 · Decision Aug 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    MAMMOMAT Revelation with Tomosynthesis Option System
    PMA Number
    P140011
    Supplement Number
    S007
    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
    August 21, 2020
    Date Received
    January 29, 2020
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) a new processing scheme for synthetic mammograms (new Insight 2D/3D), and 2) an updated Indications for Use to include Digital Breast Tomosynthesis (DBT) in combination with synthesized image sets, Insight 2D, or Insight 2D and Insight 3D, as a screening mode, for MAMMOMAT Revelation with Tomosynthesis Option.

    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