Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K131158
    Device Name
    CORVIEW
    Manufacturer
    Date Cleared
    2013-08-21

    (119 days)

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

    MARREK, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Corview software application is indicated for viewing and post-processing of cardiovascular magnetic resonance images (MRIs) to obtain Left Atrial Enhancement (LAE) quantification and visualization on a 3D model. It provides measurements of LAE within the left atrial wall. It enables: - . Importing Cardiac MRIs in DICOM format - Qualitative analysis of the cardiac MRIs using display functionality such as . panning, windowing, zooming, and navigation through series/slices and phases - . Quantitative measurement in cardiac MRIs, specifically LAE It is intended for use by qualified medical professionals experienced in examining and evaluating cardiovascular MRIs, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. The target population of Corview is not restricted. However image acquisition by an MRI scanner with cardiac capability may limit the use of the device for certain sectors of the general public. Corview is intended to view only cardiac magnetic resonance images acquired from an MRI scanner with cardiac capabilities. The CORVIEW software application is intended for use in the clinical setting.
    Device Description
    CORVIEW is an independent software solution for the segmentation and quantitative analysis of digitized cardiac magnetic resonance images (MRIs). CORVIEW operates on higher-end off-the-shelf PC or Apple computers and is compatible with Cardiac MRI digital images in DICOM format from a range of commercial MRI machine vendors. The CORVIEW software platform is also designed to process MRIs received from various modes of image exchange. CORVIEW presents a state-of-the-art method to process and quantify the extent of left atrial enhancement (LAE) within the left atrial wall by contouring and identifying the endo- and epi-cardial borders from contrast enhanced MR image sequences that have been acquired as part of a conventional cardiac MRI examination. CORVIEW is designed for the processing of 3D image datasets allowing users to produce contour models and visualizations of left atrial structure and contrast enhancement. Based on 3D-acquired datasets, a feature classification algorithm supports the calculation of LAE. From these corresponding algorithms, total percentage of enhancement can be derived. In addition, the corresponding shape of the left atrium can also be obtained.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1