AI-ECG Platform
Shenzhen Carewell Electronics., LtdThe 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.
Intended Use
The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. Interpretation results are advisory, not sole diagnosis.
Technology
The AI-ECG Platform is a distributed ECG auto-analysis software using AI algorithms to automatically measure and interpret 12-lead resting ECG data uploaded or directly acquired from compatible devices. It supports various ECG data formats and delivers interpretation for physician review and editing. The system stores waveform data securely on a server and provides a PC-based client for clinicians.
Performance
Performance and safety were verified by bench testing demonstrating compliance with standards including AAMI ANSI EC57:2012 for cardiac rhythm and ST-segment measurement algorithms, IEC 60601-2-25 for electrocardiograph safety, IEC 62304 for medical device software lifecycle, and ISO 14971 for risk management. The device was found substantially equivalent to predicate devices with successful verification.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/20/2018
9 months - 2
FDA Approval
11/19/2018
Other devices from Shenzhen Carewell Electronics., Ltd
- AI-ECG Tracker2020 • 510K
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