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510(k) Data Aggregation

    K Number
    K220034
    Device Name
    NEUROShield
    Date Cleared
    2023-09-14

    (617 days)

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

    In-Med Prognostics L3C

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NEUROShield™ medical image processing software is intended for automatic labelling, visualization, and volumetric quantification of the Hippocampus brain structure from a set of MR images.
    Device Description
    NEUROShield™ is a fully automated brain geometry-based quantifying analytics tool/cloud platform that uses Al/Deep Net to support physicians as a clinical decision support tool for neurologists and neuroradiologists. NEUROShield™ takes 3D MR images as input and calculates brain volumes that can assist physicians in devising optimal treatment plans. The Al tool branded as NEUROShield™ provides volumetric measurements of the Hippocampus brain structure. It replaces time-consuming manual processes with leading-edge automated technology that accelerates the analysis for clinical and research purposes. Brain Volume Quantification is a wellestablished methodology for differential and enhanced interpretation of medical images. We are using a locked algorithm, and any proposed modifications will be submitted to the FDA for review.
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