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510(k) Data Aggregation

    K Number
    K982208
    Device Name
    IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
    Manufacturer
    Date Cleared
    1999-08-27

    (430 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOMED IMAGING LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The indications for use of the IRL VasoScan™ intravascular ultrasound catheter are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The indications for use of the IRL VasoScan™ intravascular ultrasound imaging system are for the visualization of the lumen and structure of the coronary arteries in patients affected by atherosclerosis who are suitable candidates for percutaneous transluminal coronary angioplasty (PTCA). The IRL VasoScan™ intravascular ultrasound catheter is for use only with the IRL VasoScan™ intravascular ultrasound imaging system.
    Device Description
    The outer body of the IRL VasoScan™ intravascular ultrasound catheter is manufactured from Vestamid 12. The transducer consists of a 64-element array, supported on a polyimide film. The IRL VasoScan™ intravascular ultrasound catheter has a usable length of 1350mm and is designed to provide high quality intra-arterial ultrasound images of the coronary arteries. The IRL VasoScan™ intravascular ultrasound catheter is designed to be combined with conventional coronary angiography for the purposes of diagnosis, assistance with the choice of therapeutic modalities and assessment of the immediate outcome of such treatment.
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