# K131045: Enterprise Ecg Analysis / Interpretation Software

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Designs, LLC
- Decided: May 29, 2013 after 44 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The "Enterprise ECU Analysis / Interpretation Software" is a tool used by qualified medical professionals to assist with the assessment of arrhythmias using ambulatory EGG data. The software supports downloading and analyzing data recorded in compatible formats from devices used for arrhythmia diagnostics such as Holtet, Event Monitor, ambulatory or resting EGG devices, or other similar devices when assessment of the rhythm is necessary. The software can be electronically interfaced, and perform analysis with data transferred from other computer based EGG systems, such as an EGG management system. The software provides EGG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for the captured data. The software is not for use in life supporting or life sustaining systems or EGG Alarm devices. The software can be integrated into computerized EGG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECU metrics include beat by beat heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the care provider to render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K131045
Methodology: https://510kreport.com/methodology