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510(k) Data Aggregation

    K Number
    K181771
    Device Name
    RightEye Vision System
    Manufacturer
    RightEye, LLC
    Date Cleared
    2018-09-28

    (87 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    RightEye, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RightEye Vision System is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.
    Device Description
    RightEye Vision System detects involuntary eye movement behavior for the purpose of visual tracking. The RightEye Vision System is designed to provide accurate and reliable information for users to supplement and inform clinical decision-making. RightEye Vision System provides objective metrics acquired from eve movements measured and recorded by a hardware eye tracker that are not observable in clinical observation. Results of each RightEye Vision System assessment are transferred and stored remotely on a web server. All personal health information data are encrypted with HTTPS (HTTP Secure) protocol. The remote web server software calculates metrics from the assessment data and provides quantitative outputs and supporting graphics. The software can track the results over time showing changes in metrics, trendlines, graphs, visuals, and qaze replay. The user accesses these results by logging into the RightEye web portal. The RightEye Vision System is designed to run on Windows 10 operating systems and the web portal has been optimized for Chrome. RightEye Vision System is programmed to run on a specific hardware setup, the Tobii Dynavox i15. It is deployed as a pre-loaded system on hardware provided and managed by RightEye.
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