# K142693: ZywieAI Software Library

- Pathway: 510(k) (Traditional)
- Applicant: Zywie, Inc.
- Decided: Feb 20, 2015 after 151 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K871344 (1987). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 4.
- K031466: Iqmark Digital Holter, Brentwood Medical Technology Corp. (2003) Summary page 4.

## Indications for use
The ZywieAl Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAl Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring. Verification of the output from ZywieAl Software is the responsibility of a trained healthcare professional or physician. The ZywieAl Software Library is used for analyzing ECG data for adult patient population.

Source page: https://510kreport.com/device/K142693
Methodology: https://510kreport.com/methodology