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510(k) Data Aggregation

    K Number
    K140828
    Device Name
    NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
    Manufacturer
    Date Cleared
    2015-02-04

    (309 days)

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

    BRAINREADER APS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroReader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
    Device Description
    Neuroreader is a medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from magnetic resonance images. The segmentation system relies on a number of atlases which each consist of a T1-weighted MR image, a binary mask covering the brain and a label map dividing the MR image into different anatomical segments. Neuroreader provides an estimation of the normal volume for a person with similar demographic data. This is done based on a statistical model and a database of healthy material. Neuroreader is intended to automate the current manual process of identifying, labeling and quantifying the volume of brain structures identified on MR images. Neuroreader is aimed to be a support tool for clinicians in assessing structural MRIs. Neuroreader describes the analysis results in a self-explicative volumetric report within an analysis-time of 10 minutes.
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