FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
510k6/25/2019
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.
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