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    K Number
    K024028
    Device Name
    SHARP VIEW IMAGE ENHANCEMENT SYSTEM
    Manufacturer
    CONTEXT VISION AB
    Date Cleared
    2003-01-24

    (49 days)

    Product Code
    LLZ, 90L
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTEXT VISION AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of multi-modality images from a variety of diagnosis imaging systems.
    Device Description
    The product is a software or a kit containing software and hardware (Image processing board), which is intended to be installed on a personal computer. Typically the personal computer receives digital medical images in DICOM 3 format over a network connection. The enhanced and original image can be sent in DICOM 3 format over the network connection. The original file and the enhanced file can be kept locally if selected.
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