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510(k) Data Aggregation

    K Number
    K024201
    Device Name
    NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
    Manufacturer
    IMAGE-GUIDED NEUROLOGICS, INC.
    Date Cleared
    2003-03-12

    (82 days)

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

    NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000

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

    The Navigus Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic provide The device is provided sterile and is for one time use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the Navigus Fiducial Marker System. It confirms the substantial equivalence of the device to a predicate device and allows it to be marketed, but it does not contain the detailed study information (acceptance criteria, reported performance, sample sizes, ground truth, etc.) that you are requesting.

    The letter focuses on regulatory approval and compliance, not the technical study results. Therefore, I cannot extract the specific information you asked for based on this document.

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