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    K Number
    K221544
    Device Name
    MagVenture TMS Atlas Neuro Navigation System
    Manufacturer
    Tonica Elektronik A/S
    Date Cleared
    2023-03-17

    (294 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K191422
    Why did this record match?
    Device Name :

    MagVenture TMS Atlas Neuro Navigation System

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

    The MagVenture TMS Atlas Neuro Navigation System is a neuronavigation system indicated for accurate positioning of the treatment coil of the MagVenture TMS Therapy system with respect to target brain regions based on data obtained from MRI measurements. Specifically, the MagVenture TMS Atlas Neuro Navigation System is indicated for use with the following MagVenture treatment coils manufactured by Tonica Elektronik A/S: C-B60, Cool-B70, Cool DB80, MCF-B65, MCF-B70, and C-B70.

    Device Description

    The MagVenture TMS Atlas Neuro Navigation System (TMS Atlas system) combines MRI-based, 3-D visualization of cortical areas of the brain with non-invasive TMS in order to target brain areas accurately, and to locate the target for depression therapy. The TMS Atlas software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.

    AI/ML Overview

    The provided text describes the acceptance criteria and supporting studies for the MagVenture TMS Atlas Neuro Navigation System.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceStudy Type
    Tracking System AccuracyStatic accuracy better than or equal to 1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool)1.4 mm RMS, 0.5 degrees RMS (accuracy of localization of tool)Tracking System Accuracy Test (from NDI reports)
    System Accuracy (Navigation)Navigation accuracy
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