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510(k) Data Aggregation

    K Number
    K103192
    Device Name
    NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
    Manufacturer
    ILUMARK GMBH
    Date Cleared
    2011-02-07

    (101 days)

    Product Code
    HAW, OLO
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ILUMARK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ILUMARK Navigation Markers are intended to be used as image guided surgery system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery procedures. It is indicated for any medical condition in which the use of an image guided surgery system may be considered to be appropriate. ILUMARK Navigation Markers can be used in following procedures: - Stereotactic brain surgery . - Endoscopic Sinus Surgery . - . Pedicle Screw Placement - Reconstructive orthopedic surgery . - Soft tissue treatment .
    Device Description
    ILUMARK Navigation Markers are used as accessories with image quided surgery systems. The Navigation Markers define specific locations on instruments and reference geometries. A camera system, as part of an image guided surgery system uses the location information to determine the orientation and location of an instrument relative to other instruments or reference geometries. A computer system visualizes the orientation and location of the instrument based on pre-operative data or a computer calculated model of the patients anatomy.
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