Zio AT ECG Monitoring System, ZEUS System
iRhythm Technologies, Inc.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.
Intended Use
The device is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring in adults.
Technology
The ZEUS System uses a deep learning-based rhythm classification algorithm to analyze continuously recorded ECG data. It processes digital long-term continuous ECG signals, downloads and stores the data, and integrates machine learning and deep learning classifications to generate detailed cardiac rhythm reports for clinicians.
Performance
The device's arrhythmia detection algorithm was tested according to AAMI ANSI EC57:2012 performance standards and IEC 60601-2-47:2012 safety standards for ambulatory ECG systems. Verification and system-level regression testing demonstrated that the device meets design requirements and intended use without new safety or effectiveness concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/7/2018
2 months - 2
FDA Approval
8/29/2018
Other devices from iRhythm Technologies, Inc.
- ZEUS System2023 • 510K
- ZEUS System (Zio Watch)2022 • 510K
- Zio ECG Utilization Software (ZEUS) System2021 • 510K
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