BEUDAMED
    FDA PMA 🇺🇸 United States

    PMA: P050022 · Decision Oct 18, 2006
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SYNGO LUNG CAD
    PMA Number
    P050022
    Product Code
    NRR
    Generic Name
    Lung computed tomography system, computer-aided diagnosis
    Advisory Committee
    Radiology
    Decision Code
    APCV
    Decision Date
    October 18, 2006
    Date Received
    June 30, 2005
    Expedited Review
    N
    Docket Number
    06M-0456

    Advisory Committee Statement

    APPROVAL FOR THE SYNGO LUNG CAD SOFTWARE DEVICE. THE DEVICE IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTI-DETECTOR COMPUTED TOMOGRAPHY (MDCT) EXAMINATIONS OF THE CHEST. THE SOFTWARE IS AN ADJUNCTIVE TOOL TO ALERT THE RADIOLOGIST TO REGIONS OF INTEREST (ROI) THAT MAY HAVE BEEN INITIALLY OVERLOOKED. THE LUNG CAD SOFTWARE DEVICE IS INTENDED TO BE USED AS A SECOND READER AFTER THE RADIOLOGIST HAS COMPLETED HIS/HER INITIAL READ.