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510(k) Data Aggregation

    K Number
    K991302
    Device Name
    SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
    Manufacturer
    Date Cleared
    1999-06-01

    (46 days)

    Product Code
    Regulation Number
    892.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SMARTLIGHT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartLight Digital Film Viewer System is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films. The Digital Film Viewer is a radiographic film illuminator with the following new indications for use: - The Digital Film Viewer substantially improves the ability to detect and discern radiographic objects recorded on film compared to unmasked and masked light boxes. - The Digital Film Viewer substantially improves the ability to detect and discern clinical information recorded on radiographic film compared to unmasked and masked light boxes. - The Digital Film Viewer mitigates the age-dependent degradation in the ability to detect or discern radiographic objects recorded on film for readers over 30 years of age, as experienced on unmasked and masked light boxes.
    Device Description
    The Digital Film Viewer is a radiographic film illuminator designed to automatically adapt film-viewing conditions to compensate for known physical and psychophysical limitations in human visual perception when reading radiographic films. The device senses the size, location, and density of films mounted on its faceplate and automatically adapts film-viewing conditions, as described below: - Adaptive Light Intensity The device automatically adapts the intensity of the back illumination system according to film density. Back light intensity ranges from 500-10,000 nits. - Masking The device enables electro-optical collimation of the back illumination such that those parts of the faceplate covered by films are illuminated, while the rest of the faceplate remains dark, eliminating extraneous glare. - Film Scatter Suppression The device incorporates an optical grid, which projects light in the forward direction to suppress optical scatter within the film (Callier effect). - Ambient Light The device reduces the ambient light level when films are mounted on its faceplate. - Pupil Diameter The device emits a dark blue light from its faceplate to control pupil dilation.
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