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510(k) Data Aggregation

    K Number
    K130929
    Device Name
    ZMED VP4000
    Manufacturer
    ZMED, INC.
    Date Cleared
    2013-04-12

    (9 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZMED VP4000 Video Processor is intended for use in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor are incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.
    Device Description
    The ZMED VP4000 is a simple-to install, easy to use video processing system which provides powerful real-time enhancement of input video signals. The enhanced output video provides increased clarity, contrast, and detail, aiding in the ability to see through smoke, in poor lighting conditions, and other suboptimal conditions. The VP4000 is connected between a video source and a display. The system uses standard electronic components to implement patented algorithms which are designed to improve the ability of the human eye to perceive fine details in the image which might otherwise be obscured by smoke, haze, poor lighting, etc. This is accomplished via a combination of locally-adaptive contrast enhancement using a very large-kernel convolution operation (identical to that used in the CE3000), and histogram-based operations. Like the CE3000, a key feature of the VP4000 is its ability to perform these complex operations in real time, adding virtually imperceptible system latency from input of raw video to output of enhanced video. The effectiveness of the algorithms combined with this real-time capability makes the VP4000 ideally suited for use in applications which live video is required to perform a given function. The VP4000 chassis is constructed of lightweight aluminum, measures 15.7" wide by 12.0" deep by 1.7" high, and weighs 4.95 pounds. The device is compatible with DVI-D and HD-SDI video signals in a variety of standard resolutions, up to 1080p. Internally, the VP4000 is constructed using UL- and IEC-approved components, circuit boards, and harnessing.
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