BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Breast Ultrasound

    PMA: P200040 · Decision Oct 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Automated Breast Ultrasound
    Trade Name
    SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
    PMA Number
    P200040
    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
    October 6, 2021
    Date Received
    September 3, 2020
    Expedited Review
    N
    Docket Number
    21M-1352

    Advisory Committee Statement

    Approval for the SoftVue System. The device is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women with dense breast parenchyma after confirmation that the breast density composition is BI-RADS c or d at the time of screening mammography. The device is intended to increase breast cancer detection in the described patient population relative to mammography alone. The device is not intended to be used as a replacement for screening mammography. The device can be used at the same visit as screening mammography and SoftVue images are intended to be interpreted with the mammogram results to enhance screening.

    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