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510(k) Data Aggregation

    K Number
    K141922
    Device Name
    IRIS INTELLIGENT RETINAL IMAGING SYSTEM
    Date Cleared
    2015-02-27

    (226 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTELLIGENT RETINAL IMAGING SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRIS Intelligent Retinal Imaging Systems is a comprehensive web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data and images from computerized diagnostic instruments or systems. Original and color amplified images can be viewed by trained healthcare professionals.
    Device Description
    The IRIS software is a software as a service application that is hosted on the internet which allows clinicians the ability to scan a patient's retina with a fundus camera, transmit the images up to a website and offer an opinion on the scans. It also allows users the ability to input data relative to a visual fields exam. The combination of a fundus picture and visual fields data allows a licensed/credentialed clinician to evaluate the patient for glaucoma.
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