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510(k) Data Aggregation

    K Number
    K993802
    Device Name
    SHARPVIEW IMAGE ENHANCEMENT SYSTEM
    Manufacturer
    CONTEXTVISION AB
    Date Cleared
    2000-01-18

    (70 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    CONTEXTVISION 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 MRI images.
    Device Description
    The product is a kit containing software and hardware (PCI graphics processor board) which is intended to be installed on a personal computer. Typically the personal computer receives MRI images in DICOM 3 format over a network connection. The received image is stored locally, then accessed, then enhanced by the software/hardware combination, then stored in the enhanced format. The original file can still be accessed and is not modified.
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