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510(k) Data Aggregation

    K Number
    K153239
    Device Name
    LSFG-NAVI
    Manufacturer
    Date Cleared
    2016-05-12

    (185 days)

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

    Softcare Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laser Speckle Flowgraphy LSFG-NAVI system is intended to capture and display the blood flow distribution in the human retina in real time, and to monitor the blood flow in retinal vessels for their quantitative evaluation.
    Device Description
    The LSFG-NAVI can visualize and measure the distribution of blood flow in the human retina in a broad area from macular to the optic nerve head. The most useful feature of the instrument is the ability to non-invasively observe varying blood flow synchronized with the heartbeat as a series of 2D blood flow maps. The LSFG-NAVI consists of following major units: - (1) LSFG-NAVI Camera Unit: including an emitter of a diode laser, retinal camera imaging system, imager, CCD camera (video capturing) - (2) Personal Computer (PC): including LSGF-NAVI System Software (Measurement Software and Analysis Software - (3) 3D-Stage Unit: The LSFG-NAVI Camera Unit is attached to the 3D-Stage unit and a patient places his/her head and face at Chin Rest and Head Rest of the 3D-Stage Unit. - (4) Electronic Unit: including the AC Adapter and Isolation Transformer.
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