Zio ECG Utilization Software (ZEUS) System
iRhythm Technologies, Inc.The Zio ECG Utilization Software (ZEUS) System is a software platform that processes and analyzes long-term continuous ECG data collected from compatible cardiac monitoring devices. It helps clinicians by automatically detecting and reporting cardiac arrhythmias and other relevant heart rhythm information, assisting in the diagnosis and management of cardiac conditions.
Intended Use
The device is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring.
Technology
The ZEUS System consists of software modules designed to store and analyze ECG data from compatible single-patient-use cardiac monitoring devices, producing preliminary findings such as beats, ectopic runs, rhythm segments, and heart rate measurements. It uses automated ECG analysis algorithms, with quality control by Certified Cardiographic Technicians, and supports interoperable use with Zio XT and Zio AT Patch devices.
Performance
The device conforms to FDA-recognized consensus standards and guidance documents. Nonclinical testing including software lifecycle, risk management, and electrical safety was conducted. No clinical testing was performed. The modifications from the predicate device did not affect safety or effectiveness, demonstrating substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/1/2020
8 months - 2
FDA Approval
5/21/2021
Other devices from iRhythm Technologies, Inc.
- ZEUS System2023 • 510K
- ZEUS System (Zio Watch)2022 • 510K
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring System2019 • 510K
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