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510(k) Data Aggregation

    K Number
    K073194
    Device Name
    CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
    Manufacturer
    CARDIOVASCULAR IMAGING SOLUTIONS LTD.
    Date Cleared
    2008-02-14

    (93 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOVASCULAR IMAGING SOLUTIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™ is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plugins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis. Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device. The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals. Only DICOM images will be used for presentation, display and diagnosis.
    Device Description
    CMRtools™ is a software package for the visualization and analysis of cardiovascular magnetic resonance images (CMR). CMRtools™ is comprised of an image loader, an image viewer and a set of optional plug-ins for specialist cardiac analysis, including VentricularTools and ThalassaemiaTools. - VentricularTools provides dedicated functionality for calculating volume and mass indices of the . ventricles of the heart from magnetic resonance images. - ThalassaemiaTools allows the calculation of a property called T2* that characterizes iron loading . in the heart and liver. CMRtools™ allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session record for providing comprehensive audit trails.
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