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510(k) Data Aggregation

    K Number
    K240385
    Device Name
    VINT
    Date Cleared
    2024-10-15

    (250 days)

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

    Mediimg Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format). It enables: - Importing DICOM-compliant MR Images. - Quantitative analysis of imported images. - Visualization and analysis of blood flow characteristics of cerebral arteries in MR images. - Advanced correction options such as offset correction, background phase correction, and anti-aliasing. - Data visualization as a graph or output as an image or numerical data. - Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA. VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
    Device Description
    VINT is a standalone medical software device designed for processing, analyzing, viewing, and quantifying cerebral artery MR images. The software is intended to visualize and quantify MRI data imported in DICOM format. The key functions of the VINT software are 2D and 3D viewing, multiphase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table. It can also be used to analyze multi-slice signal intensity gradient of a TOF-MRA to visualize and analyze the blood flow characteristics of cerebral arteries, without any-contrast medium for MR angiography.
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