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510(k) Data Aggregation

    K Number
    DEN180001
    Device Name
    IDx-DR
    Manufacturer
    Date Cleared
    2018-04-11

    (89 days)

    Product Code
    Regulation Number
    886.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    IDx, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IDx-DR is indicated for use by health care providers to automatically detect more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.
    Device Description
    The IDx-DR consists of several components. A fundus camera is attached to a computer, where the IDx-DR Client is installed. The Client allows the user to interact with the server-based analysis software over a secure internet connection. Using the Client, users identify two fundus images per eye to be dispatched to IDx-Service is installed on a server hosted at a secure datacenter. IDx-DR Analysis, which runs inside IDx-Service, processes the fundus images and returns information on the image quality and the presence or absence of mtmDR to IDx-Service. IDx- Service then returns the results to the IDx-DR Client.
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