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 EnSite™ X EP System is a computerized diagnostic tool that helps visualize and map the electrical activity of the heart during electrophysiological procedures. It displays the 3D position of catheters inside the heart and creates detailed maps of cardiac chambers to aid clinicians in diagnosing and treating heart rhythm disorders.

FDA #
K251234
Product Code
DQK
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