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510(k) Data Aggregation

    K Number
    K210396
    Device Name
    Harmony Referral System
    Manufacturer
    Topcon Healthcare Solutions EMEA Oy
    Date Cleared
    2021-09-13

    (215 days)

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

    Topcon Healthcare Solutions EMEA Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.
    Device Description
    Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements.
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