ZEUS (ZIO ECG Utilization Service) System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091075 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ZEUS (ZIO ECG Utilization Service) System is a cardiovascular device designed for electrocardiogram (ECG) data processing and analysis. It is substantially equivalent to predicate devices and has been reviewed by the Cardiovascular advisory committee.
The system is authorized under FDA 510(k) clearance (K091075) and is manufactured by iRhythm Technologies, Inc. It is supplied as a non-sterile, reusable system intended for use in clinical settings to support ECG utilization services.
Frequently asked questions
What is the ZEUS ZIO ECG Utilization Service System used for?
The ZEUS system is designed for electrocardiogram (ECG) data processing and analysis. It supports ECG utilization services in clinical settings by enabling the interpretation and management of ECG data, helping clinicians assess cardiac activity through automated analysis tools.
Is the ZEUS system sterile or non-sterile, and is it intended for single use or reuse?
The ZEUS system is supplied as a non-sterile, reusable system. It is intended for repeated use in clinical environments after appropriate cleaning and maintenance, as it is not designed to be discarded after a single patient encounter.
How is the ZEUS system supplied and what regulatory pathway was used for its authorization?
The ZEUS system is supplied as a reusable, non-sterile device for clinical ECG data processing. It received authorization through the FDA 510(k) pathway under clearance K091075, demonstrating substantial equivalence to predicate devices in the cardiovascular monitoring category.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ZEUS WebServices - Login
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091075 | Class II | Active |
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Manufacturer
- Manufacturer
- Irhythm Technologies, Inc.
Sources (1)
- FDA 510(k) K091075 24 fields · synced Sep 21, 2026