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    K Number
    K981856
    Device Name
    MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
    Manufacturer
    GREATBATCH SCIENTIFIC
    Date Cleared
    1998-07-29

    (63 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GREATBATCH SCIENTIFIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MR Endoscopic Video System is intended to digitally generate and display an image captured from a rigid or flexible endoscope during a minimally invasive interventional MR surgical procedure.
    Device Description
    The MR Endoscopic Video System consists of a color camera signal processor (PAL or NTSC), camera head, color video monitor and all associated cables. The camera is powered by a 19 volt (PAL) or 15 volt (NTSC) battery pack. The video monitor is powered by a 110 volt AC to 12.5 volt DC medical-grade power supply attached to the end of a 20 foot shielded cable. The camera head attached to endoscopes by a non-conductive snap-lock coupling. The camera is connected to the video monitor via a cable. The endoscopic image can then be displayed to a remotely located video monitor.
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