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IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retimopathy (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.

The IDx-DR device is an autonomous, artificial intelligence (AI)-based system for the automated detection of more than mild diabetic retinopathy (mtmDR). It consists of several component parts: IDx-DR Analysis, IDx-DR Client, and IDx-DR Service. The IDx-DR Analysis software analyzes patient images and determines exam quality and the presence/absence of mtmDR. The IDx-DR Client is a software application running on a computer connected to the fundus camera, allowing users to transfer images and receive results. The IDx-DR Service comprises a general exam analysis service delivery software package with a webserver front-end, database, and logging system, and is responsible for device cybersecurity. The system workflow involves image acquisition using the Topcon NW400, transfer to IDx-DR Service, analysis by IDx-DR Analysis System, and display of results on the IDx-DR Client.

IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. IDx-DR is indicated for use with the Topcon NW400.

The IDx-DR device consists of several component parts. A camera is attached to a computer, where IDx-DR client is installed. Guided by the Client, users acquire two fundus images per eye to be dispatched to IDx-Service. IDx-Service is installed on a server hosted at a secure datacenter. From IDx-Service, images are transferred to IDx-DR Analysis. No information other than the fundus images is required to perform the analysis. IDx-DR Analysis, which runs on dedicated servers hosted in the same secure datacenter as IDx-Service, processes the fundus images and returns information on the exam quality and the presence or absence of mtmDR to IDx-Service. IDx-Service then transports the results to the IDx-DR Client that displays them to the user.