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510(k) Data Aggregation

    K Number
    K250770
    Date Cleared
    2025-09-04

    (175 days)

    Product Code
    Regulation Number
    886.1120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Optina-4C™ is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying, storing, and transferring images of the retina. The Optina-4C is indicated for the viewing of the posterior segment of the eye at multiple wavelengths (colors) under mydriatic conditions.

    Images are intended to aid clinicians in the detection, diagnosis, and management of ocular health and disease.

    Device Description

    The Optina-4C™ (MHRC-C1N) is a non-contact mydriatic retinal camera (also called a fundus camera) designed to provide eye care professionals with a series of images of the retina obtained at specific wavelengths (colors). The Optina-4C processes images using algorithms that take advantage of the spectral information to produce 2D en face images of the retina as an aid to clinicians in the diagnosis of age-related macular degeneration (AMD), retinal pigment epithelium (RPE) disruptions and lesions, retinopathies, and other retinal diseases.

    Utilizing Hyperspectral Imaging (HSI) technology, the Optina-4C captures a series of 92 high-resolution images at precise 5 nm wavelength increments across the visible and near-infrared (NIR) spectrum on a ~31° field-of-view. Image acquisition takes under two seconds, with only 0.92 seconds of light exposure time. During this time, the camera scans through all wavelengths from 905 to 450 nm, spending 10 milliseconds per 5 nm step.

    The Optina-4C processes the images to provide spectrally calibrated, normalized, and registered images in a structured Hyperspectral Cube format for scroll-through viewing. The spectral resolution supports visualization and differentiation of drusenoid deposit types, as well as high contrast viewing of the retinal chromophores hemoglobin, melanin, and carotenoids (combination of lutein and zeaxanthin). Images can be viewed, stored or transferred in their native .h5 format, or as DICOM or PNG formats. Optina-4C images offer sharp, vivid, high-contrast coronal views of the posterior segment of the eye for clinical assessment and evaluation by eye care professionals.

    The HSI NormReg Cube is a processed data set of 91 hyperspectral images that have undergone intensity normalization and spatial registration. Normalization corrects for the non-uniform illumination profile of the imaging system and the spectral sensitivity of the camera, while registration compensates for intra-scan eye movement to ensure consistent alignment across frames. The result is a hyperspectral image cube with enhanced spatial and spectral fidelity, referred to as the HIS-NormReg Cube.

    AI/ML Overview

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