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510(k) Data Aggregation

    K Number
    K073372
    Device Name
    ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
    Manufacturer
    SYSTEMSONE
    Date Cleared
    2007-12-07

    (4 days)

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

    SYSTEMSONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.
    Device Description
    The EPSI is a video integration system that uses a video splitter to take the original source image from a device and send it out to a variety of locations, such as the original intended monitor, a hemodynamics recording system in the control room, etc. The split image is then sent into the EPSI system (Flat Panel LCD monitor) and a Keyboard-Video-Mouse (KVM) switch. The display on the LCD at any time is controlled by a touchpad panel.
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