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

    Analyzer, Medical Image

    PMA: P000041 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    RAPIDSCREEN RS-2000
    PMA Number
    P000041
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    July 12, 2001
    Date Received
    October 10, 2000
    Expedited Review
    Y
    Docket Number
    01M-0306

    Advisory Committee Statement

    APPROVAL FOR THE RAPIDSCREEN(TM) RS-2000. THE DEVICE IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITIZED FRONTAL CHEST RADIOGRAPHS. IT IDENTIFIES FEATURES ASSOCIATED WITH SOLITARY PULMONARY NODULES FROM 9 TO 30 MM IN SIZE, WHICH COULD REPRESENT EARLY-STAGE LUNG CANCER. THE DEVICE IS INTENDED FOR USE AS AN AID ONLY AFTER THE PHYSICIAN HAS PERFORMED AN INITIAL INTERPRETATION OF THE RADIOGRAPH.

    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