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    K Number
    K102599
    Device Name
    TOMOPHASE OCTIS
    Manufacturer
    TOMOPHASE CORPORATION
    Date Cleared
    2010-12-01

    (82 days)

    Product Code
    NQQ, NOO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOMOPHASE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tomophase OCTIS (Optical Coherence Tomography Imaging System) is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
    Device Description
    The Tomophase OCTIS is an imaging tool for the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. The system consists of an Imaging Console and a detachable Probe. The Imaging Console contains optical and electrical components to utilize NIR light to create high resolution real-time images; and has a user interface for acquiring, displaying, saving and reporting the images. The Probe is a single-use, sterile device consisting of a sealed sheath and a flexible fiber optic mechanism.
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