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510(k) Data Aggregation

    K Number
    K251927
    Device Name
    Zeta Navigation System (ZNS131-US)
    Manufacturer
    Zeta Surgical Inc.
    Date Cleared
    2025-10-10

    (109 days)

    Product Code
    SGE
    Regulation Number
    N/A
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K223577
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeta TMS Navigation System is a stereotaxic image guidance system intended for accurate positioning of the treatment coil of TMS systems with respect to target brain locations based on data obtained from 3D patient imaging.

    The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R30 stimulator, the R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: Cool-B65 RO.

    Device Description

    The Zeta TMS Navigation System is a stereotaxic, image guided planning and intraoperative guidance system enabling computer-assisted cranial interventional procedures. The system assists trained clinical professionals with the precise positioning of interventional instruments relative to patient anatomy by displaying the position of navigated interventional instruments relative to 3D preoperative medical scans.

    AI/ML Overview

    N/A

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