ZEUS (ZIO ECG Utilization Service) System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K142681

Identifiers

510(k) Number: K142681 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 ZEU (ZIO ECG Utilization Service) System is a highly advanced, computer-based cardiovascular diagnostic system designed to provide accurate and timely electrocardiogram (ECG) interpretations. This innovative device utilizes artificial intelligence and machine learning algorithms to analyze and interpret complex ECG signals, enabling healthcare professionals to make informed decisions about patient care.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K142681	Class II	Active

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Manufacturer

Manufacturer: Irhythm Technologies, Inc.

Sources (1)

FDA 510(k) K142681 24 fields · synced Jun 29, 2026