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.

The CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.

FDA #
K243878
Product Code
QER

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.

FDA #
K191194
Product Code
QER
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