FDA Radiology AI Devices

The CLARUS 700 by Carl Zeiss Meditec, Inc. is a high-resolution ophthalmic imaging device used for capturing and analyzing images of the retina and ocular structures. It supports multiple imaging modes including true color, autofluorescence, and fluorescein angiography, aiding clinicians in diagnosing and monitoring retinal diseases by providing widefield and ultra-widefield views with AI assistance for optic nerve detection and montage creation. The device improves patient comfort and provides advanced tools for image annotation and review.

IDx-DR is an AI-based retinal diagnostic software designed to automatically detect more than mild diabetic retinopathy in adults with diabetes using retinal fundus images acquired with a specific fundus camera. It helps clinicians by providing screening results that indicate the presence or absence of disease, enabling timely referral and treatment to prevent vision loss.

The IRIS Intelligent Retinal Imaging System is a web-based software that stores, manages, and displays retinal images and diagnostic data from computerized instruments. It allows licensed clinicians to review fundus images and visual field data to evaluate and diagnose retinal conditions such as diabetic retinopathy, glaucoma, and macular degeneration, thereby assisting in patient care and follow-up.