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510(k) Data Aggregation

    K Number
    K020888
    Device Name
    FUNDUS AUTOIMAGER
    Manufacturer
    VISUAL PATHWAYS, INC.
    Date Cleared
    2002-11-07

    (234 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISUAL PATHWAYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fundus AutoImager™ is an automated ocular fundus imaging device that allows for the rapid capture, storage, manipulation and transmission of images of the eye, especially the retina area, as an aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
    Device Description
    The Fundus AutoImager utilizes video cameras for alignment, focus and tracking of the patient's pupils and a high-resolution (1k x 1k) chargecoupled device (CCD) camera for focus and tracking of the fields of interest on the patient's fundus. The system acquires stereo pairs of images that are displayed on a video monitor. The operator can select for imaging in monochrome or color and the images can be stored to disk, printed, or sent to a remote location via the Internet.
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