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510(k) Data Aggregation

    K Number
    K101810
    Device Name
    3DHJD CAMERA SYSTEM MODEL
    Manufacturer
    VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
    Date Cleared
    2010-08-30

    (62 days)

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

    VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
    Device Description
    The Viking 3DHD Video Camera System consists of camera heads, 3D endoscopes, and a camera controller. The system can be used with commercially available light sources, light cables, 2D endoscopes, couplers, and 2D and 3D video monitors or head mounted displays.
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    K Number
    K081585
    Device Name
    ENDOSCOPY VIDEO CAMERA SYSTEM
    Manufacturer
    VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS
    Date Cleared
    2008-06-20

    (15 days)

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

    VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopy Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
    Device Description
    The Endoscopy Video Camera System consists of a camera head and a camera controller. The system can be used with commercially available endoscopes and light sources and video monitors or head mounted displays.
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