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510(k) Data Aggregation

    K Number
    K132183
    Device Name
    DICOM VIDEO
    Manufacturer
    BAR CODE COMPUTER LTD
    Date Cleared
    2013-10-03

    (80 days)

    Product Code
    LMA, COM
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAR CODE COMPUTER LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DICOM Video software package is intended for use by authorized personnel to acquire individual or sequences of images and to allow the user to input patient demographics related to the image. The device transforms imaging studies to DICOM format before they are made available to other locations in the network. The DICOM Video is indicated to receive studies in various digital formats (text, still images and video) or digitized video signals from acquisition host devices. The device operations include capturing the data, recording, storing, editing and transferring it to the clinic PACS as DICOM files.
    Device Description
    The DICOM Video is a software package, which is installed in an Off - The - Shelf Host PC. The device is interfaced and configured to a hospital Local Area Network (LAN). The DICOM Video receives patients' list from the Hospital Modality Work List (MWL ) server and digital files input data (in text, images or video formats). The device records the received data, stores it, transfers the studies into standard DICOM files, and transmits the DICOM files via the LAN to the Hospital PACS. The DICOM Video can be interfaced to a Host Acquisition Device in order to receive analog video signals. The data is digitized, stored, optionally edited, transferred into standard DICOM files, and transmitted as DICOM files via the LAN to the Hospital PACS. The device can also retrieve DICOM studies from the PACS and display them on the user screen.
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