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510(k) Data Aggregation

    K Number
    K083321
    Device Name
    CARDIO-VIEW
    Manufacturer
    CURLVIEW IGT, LLC
    Date Cleared
    2008-11-26

    (15 days)

    Product Code
    DXJ
    Regulation Number
    870.2450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURLVIEW IGT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardio-View system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments commonly used in a medical procedure laboratory into a single video display. Control of the video sources is accomplished using a touchpad device.
    Device Description
    Cardio-View is a very large screen monitor for integrating the outputs from multiple video sources onto a single display. This unit is ideally suited for training labs where physicians and medical technologists can simultaneously view the disparate systems in use in the procedure rooms for complex procedures such as electrophysiology and heart surgery. The single display can be set up with customized views of many different procedure room activities to emphasize a particular area of interest while still providing the ability to monitor many others. For example, the display might simultaneously show the information being provided by an anesthesiology monitoring system, an EKG monitoring system, a CAT/MRI simulator, and fluoroscope; with each optimally-positioned for the type of procedure underway. While the display is primarily designed as an integrator and repeater of the many individual monitors typically in use in the procedure room; there is really no limit as to where it can actually be used.
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