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    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P030007 · Decision Nov 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    KODAK MAMMOGRAPHY CAD ENGINE
    PMA Number
    P030007
    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    Approved (Withdrawn)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
    November 23, 2004
    Date Received
    March 31, 2003
    Expedited Review
    N
    Docket Number
    05M-0087

    Advisory Committee Statement

    APPROVAL FOR THE KODAK MAMMOGRAPHY CAD ENGINE. THE KODAK MAMMOGRAPHY CAD ENGINE IS A SOFTWARE PACKAGE INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SOFTWARE 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