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510(k) Data Aggregation

    K Number
    K980234
    Device Name
    THE NETWORK SYSTEM
    Manufacturer
    Date Cleared
    1998-06-17

    (146 days)

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

    MEDICAL SNI LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include: Acquisition of the Network System from all medical modalities and digitized films. Storage archive is managed by a database. Distribution and wide area networks based on standard TCP protocols. Review Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.
    Device Description
    The Network System is a Picture Archiving and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice. The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.
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