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510(k) Data Aggregation

    K Number
    K110869
    Device Name
    CARA
    Manufacturer
    Date Cleared
    2011-07-14

    (107 days)

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

    DIAGNOS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CARA is a comprehensive software platform intended for importing, processing, and storing of color fundus images as well as visualization of original and enhanced image through computerized networks.
    Device Description
    CARA is a software platform that collects, enhances, stores, and manages color fundus images. Through the internet, CARA software collects and manages color fundus images from a range of approved computerized digital imaging devices. CARA enables a real-time review of retinal image data (both original and enhanced) from an internet-browser-based user interface to allow authorized users to access and view data saved in a centralized database. The system utilizes state-of-the-art encryption tools to ensure a secure networking environment.
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