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510(k) Data Aggregation

    K Number
    K093717
    Device Name
    C-MOR VISUALIZATION DEVICE
    Manufacturer
    AXIS SURGICAL TECHNOLOGIES, INC
    Date Cleared
    2010-03-02

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIS SURGICAL TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
    Device Description
    The C-MOR Visualization Device is a battery operated, portable, visualization device including an integrated LCD monitor and probe. The C-MOR Visualization Device is easily handled in one hand and includes a user interface, electronics, user controls, and LED light source. The LCD monitor displays real-time images from the probe and is flexibly mounted on the handle - allowing adjustment of the LCD viewing angle. The probe extends from the handle as a rigid shaft seating a CMOS camera and fiber optic lighting located at the distal tip. The overall length of the C-MOR Device 342 mm (approx. 13.5 inches); including the probe portion and handle. The probe length, extending from the handle, is 150 mm (approx. 6 inches). The entire unit weighs less than 300 grams (approx. 0.67 lbs.).
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