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510(k) Data Aggregation

    K Number
    K080290
    Device Name
    XVIEWNET
    Manufacturer
    AMERICAN RADIOLOGIST NETWORK, INC.
    Date Cleared
    2008-02-22

    (18 days)

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

    AMERICAN RADIOLOGIST NETWORK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The xViewNet software is intended as a display and analysis tool for the interpretation of diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended to provide access to covered entities for clinical review, throughout the healthcare facility and at the point of image acquisition. This device is not intended for mammography use
    Device Description
    x ViewNet is a secured imaging system that is used to view, edit, manipulate, annotate, analyze, and store images and data that are stored and managed in the web-based RIS. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data. Images sent to xViewNet are converted into formats suitable for viewing in its framework, and temporarily stored in a local cache memory. The algorithms used by xViewNet to view JPEG and JPEG 2000 images follow known and acceptable protocols. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state. The xViewNet software includes advanced visualization such as 3-D multiplanar reconstruction of the 2-D images. x ViewNet uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to XViewNet.
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