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510(k) Data Aggregation

    K Number
    K181501
    Device Name
    Afina
    Date Cleared
    2018-11-02

    (148 days)

    Product Code
    Regulation Number
    892.2050
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    Applicant Name (Manufacturer) :

    NeuroVision Imaging, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Afina software is intended for importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field (a circular 50-degree field of view at 20 degrees above fixation) of the retina. Afina is indicated for use only with images collected with validated ophthalmic cameras.
    Device Description
    Afina is software that transforms a set of field-identical autofluorescent (AF) images captured with a fundus camera into a single enhanced image with improved quality characteristics. It identifies and quantifies AF findings over the retinal AF background within the derived image. Afina supports licensed healthcare professionals in importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field of the retina. Functionally, Afina imports a set of at least 8 AF images taken of the superior field of the retina (also referred to as a DICOM study), combines them in order to enhance image quality, and then identifies pixels and areas of contiquous pixels (spots) that exhibit autofluorescence that is brighter than the retinal AF background. Once identified, these pixels are quantified as both a count of spots and an overall sum of pixels. These data are consolidated into a single-field patient report that presents images of the field with AF findings identified and spot and pixel counts quantified.
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