BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P010038 · Supplement: S008 · Decision Sep 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
    PMA Number
    P010038
    Supplement Number
    S008
    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
    Decision Code
    APPR
    Decision Date
    September 1, 2004
    Date Received
    June 24, 2004
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM WITH THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM AND IS INDICATED FOR: THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.

    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