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510(k) Data Aggregation

    K Number
    K192531
    Device Name
    QyScore Software
    Manufacturer
    Qynapse
    Date Cleared
    2019-12-13

    (88 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    Qynapse

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QyScore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data. QyScore is not intended for use in clinical scenarios that require evaluation of the white matter hyperintensities.
    Device Description
    QyScore automatically provides segmentations and measures of brain structures and lesions from a set of MR images for patients between the ages of 20 and 90. The software retrieves DICOM MRI data (3DT1 and T2FLAIR series) from a DICOM server and sends it to an analysis server for automatic segmentation of grey matter, white matter, hippocampus, amygdala and white matter hyperintensities. The outputs of the software include an electronic report and color overlays of the segmentation on the input images. The results are displayed in a dedicated graphical user interface, allowing the user to: - . Browse the segmentations and the measures, - Compare the results of segmented brain structures to a reference healthy population, ● - Read and edit a PDF report. QyScore integrates with leading RIS/PACS systems and can be operated with any MRI scan from 1.5T and 3T scanners for T1 MRI processing, and 3T scanners for T2FLAIR MRI processing.
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