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510(k) Data Aggregation

    K Number
    K983539
    Device Name
    TRAJECTORY GUIDE, MODEL # TGX-XXX
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    1999-02-12

    (126 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of neurological instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MRI imaging. The Trajectory Guide is intended as an aid in procedures that have traditionally used stereotactic methodology. These procedures include catheter placement and electrode implant. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA Pre-Market Notification does not contain information on the acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an approval letter for the Trajectory Guide (K983539), indicating that the FDA found it substantially equivalent to previously marketed devices. It outlines the regulatory classification and general controls applicable to the device but does not detail the technical performance or supporting studies.

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