BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P110006 · Decision Sep 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
    PMA Number
    P110006
    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
    September 18, 2012
    Date Received
    February 11, 2011
    Expedited Review
    N
    Docket Number
    12M-1011

    Advisory Committee Statement

    APPROVAL FOR THE SOMO-V: AUTOMATED BREAST ULTRASOUND SYSTEM (ABUS). THIS DEVICE IS INDICATED AS AN ADJUNCT TO MAMMOGRAPHY FOR BREAST CANCER SCREENING IN ASYMPTOMATIC WOMEN FOR WHOM SCREENINGMAMMOGRAPHY FINDINGS ARE NORMAL OR BENIGN (BI-RADS ASSESSMENT CATEGORY 1 OR 2), WITH DENSE BREAST PARENCHYMA (BI-RADS COMPOSITION/DENSITY 3 OR 4) AND HAVE NOT HAD PREVIOUS CLINICALBREAST 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