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510(k) Data Aggregation

    K Number
    K101861
    Device Name
    TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
    Manufacturer
    TRUEVISION SYSTEMS, INCORPORATED
    Date Cleared
    2010-12-22

    (173 days)

    Product Code
    HKI, EPT, NFJ
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRUEVISION SYSTEMS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates.
    Device Description
    The TrueVision® 3D Visualization and Guidance System is a stereoscopic highdefinition digital video camera and workstation, which operates as an adjunct to the surgical microscope during cataract surgery and the slit lamp microscope during pre-operative and post-operative image capture. The visualization system displays real-time images during eve surgery on a flat-panel, high-definition digital 3D display device positioned for live video image viewing by the surgeon and surgical personnel in the operating room. The Cataract and Refractive Toolset system combines the TrueVision FDAregistered Class 1 Device (TrueVision® 3D Visualization System for Microsurgery) with proprietary TrueWare™ software (controlled via remote keyboard with included touchpad mouse) to provide enhanced visualization and surgical quidance assistance to the surgeon during specific procedures such as Limbal Relaxing Incision, Capsulorhexis, and toric IOL positioning. Using standard pre-operative clinical data, together with surgeon-driven, onscreen templates and guides, the Refractive Cataract Toolset provides graphical assistance to the surgeon as desired during the surgery. Guidance applications include incision templates to optimize the position of limbal relaxing incisions, sizing and positioning of capsulorhexis tears, and rotational alignment of toric intraocular lenses (toric IOL).
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