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    K Number
    K994351
    Device Name
    M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Date Cleared
    2000-03-22

    (90 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESONANCE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
    Device Description
    The system consists of a pair of glasses coupled with an audio transducer and noise canceling headset. The headset decreases gradient noise by up to 30 dB and includes a microphone that permits two way communication between the technologist and the patient. The video option provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels.
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