BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S009 · Decision May 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    Invenia ABUS 2.0 Automated Breast Ultrasound System
    PMA Number
    P110006
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PAA
    Generic Name
    Automated breast ultrasound
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 11, 2018
    Date Received
    November 28, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the Invenia ABUS 2.0 Automated Breast Ultrasound System include hardware updates which include a new ultrasound beam former, ultrasound engine, and computer components. This supplement also requests approval for removal of the current review software from the PMA, and proposes that the images will now be reviewed on a workstation.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAA Automated Breast Ultrasound