BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P100007 · Decision Feb 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    BREAST COMPANION SOFTWARE SYSTEM
    PMA Number
    P100007
    Device Class
    FDA Class 2
    Product Code
    MYN
    Generic Name
    Analyzer, medical image
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Advisory Committee
    Radiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    February 10, 2012
    Date Received
    February 17, 2010
    Expedited Review
    N
    Docket Number
    12M-0172

    Advisory Committee Statement

    APPROVAL FOR THE BREAST COMPANION SOFTWARE SYSTEM. THE BREAST COMPANION IS A COMPUTER-AIDED SYSTEM INTENDED FOR IMPROVING THE ACR BI-RADS ASSESSMENT OF ULTRASOUND IMAGES OF LESIONS OF THE FEMALE BREAST AS PART OF THE DIAGNOSTIC WORKSHOP.

    Classifications

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

    Product Code Device Name
    MYN Analyzer, Medical Image