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510(k) Data Aggregation

    K Number
    K211715
    Device Name
    RetinAI Discovery
    Manufacturer
    RetinAI Medical AG
    Date Cleared
    2022-04-28

    (329 days)

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

    RetinAI Medical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RetinAl Discovery is a standalone, browser-based software application intended for use by healthcare professionals to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including: patient data, clinical images and information, reports and measurements of DICOM-compliant images. The device is also indicated for manual labeling and annotation of retinal OCT scans.
    Device Description
    The RetinAl Discovery consists of a platform which displays and analyzes images of the eye (e.g. OCT scans and fundus images) along with associated measurements (e.g. layer thickness) generated by the user through Discovery. The platform allows the user to manually segment layers and volumes in the images, it calculates the layer thickness and volume from annotated images and presents the progression of the measurement in graphs. Discovery provides a tool for measuring ocular anatomy and ocular lesion distances. The multiple views in Discovery and the measurements allow the user to assess the eye anatomy and, ultimately, assist the user in making decisions on diagnosis and monitoring of disease progression.
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