BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Supplement: S001 · Decision Jun 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM
    PMA Number
    P110006
    Supplement Number
    S001
    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
    June 17, 2013
    Date Received
    March 7, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW TRANSDUCER, NEW PRE-SET COMPRESSION ASSIST FUNCTION, AND OTHER SOFTWARE AND COMPUTER HARDWARE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INVENIA ABUS AND IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREASTCANCER SCREENING IN ASYMPTOMATIC WOMAN FOR WHOM SCREENING MAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BIRADSCOMPOSITION/DENSITY 3 OR 4), AND HAVE NOT HAD PREVIOUS CLINICAL BREAST INTERVENTION. THE DEVICE IS INTENDED TO INCREASE BREAST CANCER DETECTION IN THE DESCRIBED PATIENT POPULATION.

    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