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510(k) Data Aggregation

    K Number
    K023476
    Device Name
    UNIPACS WORKSTATION
    Manufacturer
    UNIVERSAL PACS, INC.
    Date Cleared
    2003-01-07

    (83 days)

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

    UNIVERSAL PACS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
    Device Description
    The UniPACS Workstation is a Windows-based software application acting as stand alone Picture Archiving and Communications System (PACS). It may be marketed as software only, as well as packaged with standard "off-the-shelf" PC hardware. The comprehensive set of tools provided in this software allows the physician to review, interpret, manipulate, print and visualize medical image data stored in DICOM format. The networking component of the product allows the physician to exchange image data with any other DICOM-compatible or FTP-compatible server over a standard TCP/IP network. The web component of the product displays workstation images in the web-browser interface, for remote review and reporting. The device does not contain the patient, nor does it control any life sustaining devices.
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