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510(k) Data Aggregation

    K Number
    K202847
    Device Name
    AccuBrain
    Date Cleared
    2021-01-15

    (112 days)

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

    BrainNow Medical Technology Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AccuBrain is a fully automated post-processing software that provides automatic labeling, visualization and volumetric quantification of hippocampus from a set of T1W MRIs and returns an analysis report.
    Device Description
    AccuBrain is a fully automated post-processing software that provides automatic labeling, visualization and volumetric quantification of hippocampus from a set of T1W MRIs and returns an analysis report. The resulting output is a morphometric report in PDF format. The software is suitable for use in both clinical trial research and routine patient care as a support tool for clinicians in assessment of structural MRIs. AccuBrain provides morphometric measurements based on 3D T1 MRI series. The output of the software includes volumes of hippocampus. The AccuBrain processing architecture includes an automated internal pipeline that performs artifact correction, segmentation, hippocampus quantification, volume calculation and report generation. Additionally, automated safety measures include automated quality control functions, such as DICOM check, age check and image resolution check and image quality check.
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