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.

EyeBOX is an eye-tracking device designed to help diagnose concussion by measuring and analyzing eye movements in patients within one week of a head injury. It uses near-infrared cameras to track gaze positions and an AI-driven algorithm to detect subtle changes in eye movements associated with concussion, aiding clinicians in neurological assessment.

FDA #
K191183
Product Code
QEA
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