BEUDAMED
    FDA PMA 🇺🇸 United States

    PMA: P030012 · Decision Jul 8, 2004
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    IMAGECHECKER CT CAD SOFTWARE SYSTEM
    PMA Number
    P030012
    Product Code
    NRR
    Generic Name
    Lung computed tomography system, computer-aided diagnosis
    Advisory Committee
    Radiology
    Decision Code
    APCB
    Decision Date
    July 8, 2004
    Date Received
    April 16, 2003
    Expedited Review
    N
    Docket Number
    04M-0323

    Advisory Committee Statement

    APPROVAL FOR THE IMAGECHECKER CT CAD SOFTWARE SYSTEM - MODEL LN-1000. THIS SOFTWARE SYSTEM IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTIDETECTOR CT (MDCT) SCANS OF THE CHEST. IT IS INTENDED TO BE USED AS AN ADJUNCT, ALERTING THE RADIOLOGIST - AFTER HIS OR HER INITIAL READING OF THE SCAN - TO REGIONS OF INTEREST (ROIS) THAT MAY HAVE BEEN INITIALLY OVERLOOKED.