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.
510k5/14/2025
Smile Dx® is an AI-powered software that assists dentists by analyzing dental X-ray images to detect issues like cavities, periapical radiolucencies, restorations, and measures bone levels. It supports digital and phosphor sensors, enhancing diagnosis and treatment planning by highlighting suspected dental findings for review, but it does not replace a dentist's judgment.
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