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510(k) Data Aggregation

    K Number
    K072972
    Device Name
    MEDSTREAMING MEDICAL OFFICE SOFTWARE
    Manufacturer
    Date Cleared
    2007-11-06

    (15 days)

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

    MEDSTREAMING, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods. The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querying and retrieving patient studies from a networked DICOM server device. MEDStreaming's Medical Office provides a means to digitize video information from connected imaging modalities using a standard video digitizing engine. The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software. The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools. The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method. MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on Medical Office utilizing Microsoft standard text, spreadsheet and database programs. MEDStreaming's Medical Office provides a means for importing and exporting patient information in HL7 format. MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.
    Device Description
    The MEDStreaming Medical Office software provides a means of opening and displaying image files. The MEDStreaming Medical Office software provides a means of transferring medical image files using a DICOM network method from the modality acquisition devices to the MEDStreaming Medical Office server. MEDStreaming's Medical Office provides a means for transferring the acquired studies to a DICOM compliant archive device using standard networking methods. The MEDStreaming Medical Office software provides a means to retrieve and view image data located on an acquisition or archive device using a standard network connection. The MEDStreaming Medical Office software provides a means for querving and retrieving patient studies from a networked DICOM server device. The MEDStreaming Medical Office software provides a means of creating AVI, BMP and JPG graphic files from the image data displayed by the software. The MEDStreaming Medical Office software provides a means of quantifying the image data using standard measurement tools. The MEDStreaming Medical Office software provides a means of transferring the DICOM Structured Reporting components provided by a connected acquisition device. MEDStreaming's Medical Office provides a means of transferring labeled measurements using a serial gateway from modality devices that support a serial data transfer method. MEDStreaming's Medical Office provides a means of generating an examination report for patient studies reviewed on the Medical Office workstation utilizing Microsoft standard text, spreadsheet and database programs. MEDStreaming's Medical Office provides a means for export results in HL7 or standard graphic file format. MEDStreaming's Medical Office provides a method for generating utilization reports for data contained within the MEDStreaming patient database using standard Microsoft database tools.
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