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.

KardiaAI is a software library by AliveCor that analyzes ambulatory ECG rhythms to identify heart conditions such as atrial fibrillation, bradycardia, and tachycardia. It supports integration into other ECG devices and helps clinicians by providing automated ECG noise filtering, heart rate measurement, and rhythm classification to inform diagnosis and monitoring.

FDA #
K181823
Product Code
DQK

The AI-ECG Platform by Shenzhen Carewell Electronics is an AI-powered software that assists healthcare professionals in measuring and interpreting 12-lead resting electrocardiograms (ECGs). It automatically analyzes ECG data, provides diagnostic interpretations for common cardiac abnormalities, and enables physicians to review and modify results. This helps clinicians make more informed cardiac assessments in hospitals and healthcare facilities.

FDA #
K180432
Product Code
DQK

The Zio AT ECG Monitoring System and its ZEUS System component are used for long-term cardiac monitoring by capturing continuous ECG data and analyzing it with AI algorithms to detect arrhythmias. The system helps clinicians by automatically detecting and reporting symptomatic and asymptomatic cardiac events, allowing improved cardiac care and diagnostics.

FDA #
K181502
Product Code
DQK
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