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510(k) Data Aggregation

    K Number
    K051809
    Device Name
    EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM
    Date Cleared
    2005-08-15

    (41 days)

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

    MEDICAL INSIGHT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Insight Easyl/iz™ PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnosis and clinical review of digital radiology images.
    Device Description
    The EasyViz(tm) system is designed as a diagnostic reading workstation system, which will be packaged with standard PC hardware and software, and is intended for use by radiologists and referring physicians. EasyViz(tm) is capable of receiving and displaying DICOM images. Images sent to EasyViz(tm) are converted into formats suitable for viewing in its framework, and are temporarily stored in a local cache (memory). The algorithms used to create JPEG and Wavelet compressed images are based on standard and accepted protocols. Images sent to EasyViz(tm) can be viewed using an executable program on a standard PC, laptop, newspaper or other devices equipped with the appropriate hardware. EasyViz(tm) uses standard "off-the-shelf" PC hardware and communicates using the standard 100 Mbit Ethernet TCP/IP stack. The network stack is superfluous to EasyViz(tm).
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