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510(k) Data Aggregation

    K Number
    K170959
    Device Name
    DIXI Medical Microdeep Depth Electrode
    Manufacturer
    DIXI Medical
    Date Cleared
    2017-11-24

    (238 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K012850,K151790,K053358
    Why did this record match?
    Reference Devices :

    K012850

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DIXI Medical Microdeep Depth Electrodes are intended for temporary (

    Device Description

    The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping.

    AI/ML Overview

    The DIXI Medical Microdeep Depth Electrode is intended for temporary (

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