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510(k) Data Aggregation

    K Number
    K193287
    Device Name
    CorInsights MRI
    Date Cleared
    2020-11-20

    (359 days)

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

    ADM Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CorInsights MRI Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from MRI images. Volumetric measurements are compared to reference percentile data. CorInsights MRI is for adults age 45 to 95.
    Device Description
    CorInsights MRI is a fully automated MR medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from DICOM formatted magnetic resonance images. The resulting output consists of a pdf report for review, which can be used in research and clinical use, and a DICOM image showing the anatomical structure boundaries identified by the software. The proposed device provides morphometric measurements based on T1 MRI series. The output of this software only device includes morphometric reports that provide comparison of measured volumes to age and gender-matched reference data and an image volume that has been annotated with color overlays representing each segmented region. The architecture has a proprietary automated internal process that includes artifact correction, atlas-based segmentation, volume calculation, and report generation. Quality control measures include automated quality control including image header checks to verify that the scan acquisition protocol and provided data adhere to system requirements, an image morphometry check, a tissue contrast check, and value range checks.
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