BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Analyzer, Medical Image

    PMA: P000041 · Supplement: S001 · Decision Jun 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Analyzer, Medical Image
    Trade Name
    RAPIDSCREEN RS-2000D
    PMA Number
    P000041
    Supplement Number
    S001
    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
    June 30, 2003
    Date Received
    February 13, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE ABILITY OF THE RAPIDSCREEN RS-2000D TO PROCESS DIGITAL IMAGES IN ADDITION TO FILM/SCREEN IMAGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RAPIDSCREEN RS-2000D AND IS INDICATED FOR: THE RS-2000D IS A COMPUTER-AIDED DETECTION (CAD) SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST (ROIS) ON DIGITAL OR DIGITALIZED 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 THE 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