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510(k) Data Aggregation

    K Number
    K231230
    Device Name
    Optina-4C (MHRC-C1N)
    Manufacturer
    Optina Diagnostics Inc.
    Date Cleared
    2023-12-05

    (221 days)

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

    Optina Diagnostics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
    Device Description
    Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm. Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation. The illumination light of Optina-4C™ is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms. The 92 images can be visualized one by one in Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ are monochromatic images having a spectral bandwidth of "10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.
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