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510(k) Data Aggregation

    K Number
    K100849
    Device Name
    SYNC-RX SYSTEM, MODEL AS00010
    Manufacturer
    SYNC-RX LTD
    Date Cleared
    2010-05-21

    (56 days)

    Product Code
    IZI
    Regulation Number
    892.1600
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    Applicant Name (Manufacturer) :

    SYNC-RX LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows: - To provide quantitative information regarding the calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
    Device Description
    The Sync-Rx System is an image acquisition and processing workstation situated in the coronary catheterization lab and intended to be used during coronary catheterizations. The Sync-Rx System captures the fluoroscopic image stream and performs the following for assisting the interventional cardiologist: Lesion Evaluation: The system performs angiogram selection and quantitative coronary measurements (lesion diameter, vessel diameter, lesion length, percent stenosis). Device positioning, deployment and post-deployment: An on-line enhanced image stream is displayed side-by-side to the existing fluoroscopic image stream. All functions performed by the Sync-Rx System are presented, both in the procedure room and in the control room, on a display that is situated side by side to the already-existing display of the native fluoroscopic image stream.
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