BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P010038 · Supplement: S005 · Decision Oct 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    ICAD SYSTEM
    PMA Number
    P010038
    Supplement Number
    S005
    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
    October 31, 2003
    Date Received
    July 29, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM, 2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND 3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE: THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM CASES FOR PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, 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