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 ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation in adult patients.

FDA #
K213409
Product Code
DQK
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