# K103427: Mobileecg System

- Pathway: 510(k) (Traditional)
- Applicant: Memtec Corp.
- Decided: Mar 24, 2011 after 122 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 K945626 (1995). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974351: Biolog 3000 Electrocardiograph, Micromedical, Inc. (1998) Summary page 1.
- K053083: Datrix Cardio Wifi Electrocardiograph, Datrix (2005) Summary page 1.
- K052883: Cardioserver, Datrix (2005) Summary page 1.
- K030535: Ekgcard System, Qrs Diagnostic, LLC (2003) Summary page 1.
- K083749: CARDIOVIEW32 Review Module, Qrs Diagnostic, LLC (2009) Summary page 1.

## Most influential descendants
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
The MobileECG System is intended to provide an analysis of rhythm and of detailed morphology of complex cardiac complexes for the resting 12 lead EGG in all situations, whether in a hospital or primary care setting. It is adjunct to the diagnosis of all commonly recognized EGG abnormalities such as myocardial infarction (Ml), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm. The MobileEGG System is intended for use in adults and children of any age from birth upwards.

Source page: https://510kreport.com/device/K103427
Methodology: https://510kreport.com/methodology