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510(k) Data Aggregation

    K Number
    K092564
    Device Name
    O-ARM IMAGING SYSTEM
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LITTLETON)
    Date Cleared
    2010-06-17

    (301 days)

    Product Code
    OXO, LHN
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC NAVIGATION, INC. (LITTLETON)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-arm® Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
    Device Description
    The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-arm® Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitor).
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