Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
iRhythm Technologies, Inc.The Zio XT and Zio AT ECG Monitoring Systems by iRhythm Technologies, Inc. analyze continuous ECG data collected via wearable patches and generate detailed reports on cardiac events. These systems help clinicians diagnose heart rhythm abnormalities by providing comprehensive, beat-to-beat ECG analysis over long monitoring periods for patients with or without symptoms.
Intended Use
The Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring in patients 18 years or older.
Technology
The ZEUS System processes and analyzes continuously recorded, single-lead ECG data collected from Zio XT or Zio AT patches. It downloads, stores, analyzes, and aggregates the data for review by certified cardiographic technicians, producing analyses with validated sensitivity and positive predictivity.
Performance
Performance testing included system performance and software verification testing to confirm the design output met design input requirements. Testing demonstrated the system's safety and effectiveness with no new issues compared to the predicate device. No clinical testing was required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/7/2019
5 months - 2
FDA Approval
8/23/2019
Other devices from iRhythm Technologies, Inc.
- ZEUS System2023 • 510K
- ZEUS System (Zio Watch)2022 • 510K
- Zio ECG Utilization Software (ZEUS) System2021 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.