BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Digital Breast Tomosynthesis

    PMA: P130020 · Supplement: S003 · Decision Dec 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20

    Basic Information

    Device Name
    Digital Breast Tomosynthesis
    Trade Name
    Senographe Pristina 3D
    PMA Number
    P130020
    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
    December 28, 2017
    Date Received
    October 26, 2017
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to Senographe Pristina 3D to add a new Digital Breast Tomosynthesis (DBT) Automatic Optimization of Parameters (AOP) table, called 3D STD+. This new AOP table enables the acquisition of DBT datasets at a dose equivalent to 2D STD+, already enabled on Senographe Pristina for 2D examination. As in 2D, the user will be able to choose which AOP table to use for 3D acquisitions: 3D STD or 3D STD+.

    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