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510(k) Data Aggregation

    K Number
    K082041
    Device Name
    FIATLUX VISUALIZE
    Manufacturer
    FIATLUX IMAGING INC.
    Date Cleared
    2008-08-01

    (14 days)

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

    FIATLUX IMAGING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FiatLux Visualize™ is a medical diagnosis software application that allows physicians, radiologists, medical technicians, nurses, and other trained medical professionals to select, review and analyze DICOM images acquired from CT and MR devices. It provides a suite of tools for 2D/3D reconstruction based on the input image dataset. FiatLux Visualize™ software must be installed on a suitable commercial computer platform. It is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Mammographic and compressed images are not supported for viewing.
    Device Description
    FiatLux Visualize™ is a medical device software application that provides multidimensional visualization of CT and MR medical images. FiatLux Visualize allows the user to select and retrieve a patient series, display and view the images and data, interactively manipulate the images to visualize anatomy and pathology, and analyze the images using a set of tools. It reads DICOM CT and MR images transferred using removable media or Microsoft Windows networking.
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