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510(k) Data Aggregation

    K Number
    K213253
    Device Name
    Pixyl.Neuro
    Manufacturer
    Pixyl SA
    Date Cleared
    2023-06-30

    (638 days)

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

    Pixyl SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Pixyl.Neuro is intended for automatic labeling, visualization of segmentable brain structures and lesions from a set of MRI images. Volumetric measurements may be compared to reference percentile data.
    Device Description
    Pixyl.Neuro is a software application for the analysis of medical images of the brain. Specifically, the application takes as input MRI images and outputs brain region volumes and lesion volumes in a report format. The application is designed to be used by clinicians treating patients with a range of neurological disorders. The application can be used in the management of patients in a routine setting and in clinical research.
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