# K091075: Zeus (Zio Ecg Utilization Service) System

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jul 21, 2009 after 98 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003621 (2000). 10 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042463: Holter Plus, Rozinn Electronics, Inc. (2004) Summary page 2.
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 2.

## Most influential descendants
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own
- K210822: DeepRhythmAI (2022), 6 descendants of its own

## Indications for use
The ZEUS System is intended for use by qualified medical professionals for assessment of a patient's recorded ambulatory ECG data. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K091075
Methodology: https://510kreport.com/methodology