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510(k) Data Aggregation

    K Number
    K201910
    Device Name
    EZTrack
    Manufacturer
    Neurologic LLC
    Date Cleared
    2020-12-22

    (166 days)

    Product Code
    OLX, OLT
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neurologic LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EZTrack is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects with focal or multifocal epilepsy at least 3 years of age for the visualization of human brain from analysis of electroencephalographic (EEG) signals produced by electrically active tissue of the brain. EZTrack calculates and displays the Fragility Index, a quantitative index based on an analysis of spatiotemporal EEG patterns that is intended for interpretation by trained physicians to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient's condition to the user and should be interpreted along with other clinical data, including the original EEG, medical imaging, and other standard neurological and neuropsychological assessments.
    Device Description
    EZTrack is a web-based software-only device that allows visualization of human brain function based on the analysis of electroencephalographic (EEG) signals. The EZTrack algorithm produces a fragility score for each EEG recording node. The EZTrack fragility values are shown to correlate with regions that clinicians have annotated as seizure onset zones (SOZ) prior to resective surgery, and may be used in conjunction with other clinical data such as EEG, medial imaging, neuropsychological testing, and other neurologic assessments in order to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient's condition. EZtrack displays the fragility of each EEG channel in a heatmap to aid in interpretation.
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