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510(k) Data Aggregation

    K Number
    K012097
    Device Name
    VORTEX
    Manufacturer
    ULTRAVISUAL MEDICAL SYSTEMS
    Date Cleared
    2001-07-12

    (7 days)

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

    ULTRAVISUAL MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is designed to provide image storage, display, and workflow integration. The image display architecture provides capabilities for near-realtime capabilities for radiologists as well as image reviewing workgroup members and other clinicians. In addition to traditional 2D image viewing functionality, the image display system provides advanced 3D features including volume rendering and multi-planar reconstruction designed to function in web-enabled viewers over both local and wide area networks.
    Device Description
    UltraVisual Vortex™ is an integrated client-server software package, which may be marketed as software only, that is used in conjunction with standard PC hardware. UltraVisual Vortex™ is a PC-based, DICOM-compliant PACS device that is able to receive, transmit and display DICOM images over both local and wide area network. Images sent to the UltraVisual Vortex™ server are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by UltraVisual Vortex™ to create JPEG and wavelet images follow known and accepted protocols. Vortex™ can be used within a hospital, a managed care facility or an isolated imaging center. It can also be used for image distribution over the network for teleradiology/review purpose. UltraVisual Vortex™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
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