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510(k) Data Aggregation

    K Number
    K082607
    Device Name
    MRI-PLAQUE VIEW, VERSION 1.1.2003
    Manufacturer
    Date Cleared
    2008-12-05

    (88 days)

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

    VPDIAGNOSTICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.0T magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as T1, T2, Proton Density, and Time of Flight. Users of MRI-Plaque View perform semiautomatic delineation of lumen and outer vessel wall boundaries. Users may also perform semi-automatic, user configurable segmentation or manual drawing for delineation of atherosclerotic plaque components within the vessel wall. Users may edit the results on the fly. The software enables length, thickness, area, and volume measurements of the vessel wall as well as quantification of user-indicated areas. MRI-PlaqueView further aids in the visualization of atherosclerotic arteries (for example, through maximum intensity projections) of MRI data and color-coded maps of segmented arteries. When interpreted by a trained physician, the output of this image analysis toolbox can be used to support the decision-making process in clinical practice or to support investigations in clinical research and trials.
    Device Description
    MRI-PlaqueView is an image analysis software toolbox that facilitates visualization and quantitative analysis of MR images of carotid arteries acquired on 1.5T or 3.0T scanners. MRI-PlaqueView provides a set of image review, delineation, registration, editing, visualization, and measurement tools. The MRI-Plaque View user interface is designed to follow typical clinical workflow patterns to review, process, edit, validate, analyze, and visualize digital images and to present, distribute and save the findings. The software application operates on a Windows XP platform that may be installed on a standalone PC, PACS or other medical imaging system. The software is designed to read MRI images from DICOM-compliant medical devices distributed by various OEM vendors. The input to the system consists of one to six standard MRI series, which provide information through use of different MRI contrast weightings, such as T1, T2, Proton Density, and TOF weighted images Once the user has selected a region of interest (ROI) for analysis, the MRI-PlaqueView tools will help to delineate the lumen and outer wall boundaries using either semi-automatic boundary detection or manual drawing/editing tools The software provide the user an option to further analyze the multiple contrast weighted MRI data using either semi-automated algorithms or manual drawing/editing tools to segment and label the internal structure of the vessel wall, delineating calcified and soft plaque regions. To facilitate the use of multiple contrast weighted data, the software displays the identified contours simultaneously on original images from all available series. Automated and user-controlled registration functions enable mapping of contours from one contrast weighting to another. The quantitative measurements this software provides include volumes, thicknesses, maximal areas, and area ratios of the different regions outlined. The software also supports review and visualization of the data using standard rendering techniques, such as maximum intensity projections. The analysis results (both contours and quantitative measurements) can be saved in separate files to facilitate restoring previous works for subsequent sessions, and for reporting results.
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