Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082808
    Device Name
    IMAGESVR PACS
    Date Cleared
    2009-01-09

    (107 days)

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

    JAGUAR TECHNOLOGY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
    Device Description
    The ImageSVR PACS is a suite of applications designed and produced by Jaguar Technology Ltd. It is a client-server based software system manages archiving, retrieving and displaying medical images. The server side application is ImageSVR PACS SERVER. And client side is ImageSVR PACS CLIENT.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1