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510(k) Data Aggregation

    K Number
    K021787
    Device Name
    VISUCAM
    Manufacturer
    CARL ZEISS OPHTHALMIC SYSTEMS, INC.
    Date Cleared
    2002-06-21

    (22 days)

    Product Code
    NFF
    Regulation Number
    892.2010
    Why did this record match?
    Product Code :

    NFF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISUCAM™ Fundus Camera is intended to capture, display and store images of eye, especially the retina area, as well as surrounding areas, to aid in diagnosing or monitoring diseases of the eye that may be observed and photographed.
    Device Description
    The VISUCAMite model is designed for a more general ophthalmology practice than the VISUPAC Fundus Camera. Therefore the VISUCAM™ is a more compact model of the VISUPAC Fundus Camera and designed for less specialized ophthalmic practices. Certain technical specifications for the VISUCAMite have been modified because the VISUCAM™ model is not designed for indocyanine angiography and imaging that requires very high image resolution, different field angles, and corresponding viewing fields. Specifically, Zeiss has modified the cleared device to: {1} reduce the light intensity; (2) eliminate specific device equipment like an external power supply unit, an external computer with storage and archiving module, and different external dedicated electronic cameras as well as dedicated photographic equipment; (3) reduce the available viewing angles and image resolution; and (4) revise the device software to accommodate less demanding image processing requirements.
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