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    K Number
    K080460
    Device Name
    SPECTRAL OCT/SLO
    Manufacturer
    OPKO HEALTH, INC.
    Date Cleared
    2008-11-14

    (268 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPKO HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectral OCT/SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device. It is indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurcment of posterior ocular structures including: retina, macula, retinanserve fibre layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. In addition, corners and conjunctiva can be imaged with the system by changing the focal position.
    Device Description
    The OPKO/OTI Spectral OCT/SLO is a computerized instrument that employs non-invasive, low-coherence interferometry to acquire simultaneous highresolution cross-sectional OCT (Optical Coherence Tomography) and confocal images of ocular structure, including retina, retinal nerve fiber layer, macula and optic disc of the eye.
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