# K142349: TM eCloud ECG Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Telemed Solutions, Inc.
- Decided: Sep 21, 2015 after 395 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: 7 generations back to K930806 (1994). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132437: Mars Holter Analysis Workstation, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 5.
- K003940: 2010 Plus Holter for Windows, Agilent Technologies (2001) Summary page 5.
- K110693: Paceart Optima System Software, Medtronic, Inc. (2011) Summary page 5.
- K103427: Mobileecg System, Memtec Corp. (2011) Summary page 5.

## Indications for use
The TM eCloud ECG Analysis System, using proprietary algorithm, is intended for use in adults and children of any age from birth upwards. The Program makes significant use of the patient’s age and gender and will provide a unique diagnosis if age differs only by a few days in the case of neonates. It is a program that is based on normal limits derived using the algorithm itself with this applying to criteria for subjects of all ages, including neonates. TM eCloud ECG Analysis System is qualified to evaluate, detect, and aid in the physician diagnosis of the following cardiac arrhythmias and/or conduction defects: • Evaluation of symptoms that may be caused by cardiac arrhythmia and /or conduction disturbances • Evaluation of symptoms that may be due to myocardial ischemia • Detection of ECG events that alter prognosis in certain forms of heart disease • Detection and analysis of indirect pacemaker function and failure • Determination of cardiac response to lifestyle • Evaluation of therapeutic interventions • Investigations in epidemiology and clinical trials • Evaluation of heart rate variability in the assessment of heart disease TM eCloud ECG Analysis System is intended to provide an interpretation of up to 12-channel ECG in all situations including resting and ambulatory ECG including Holter, cardiac event, and mobile cardiac telemetry. This software qualifies to be used in hospitals, physician offices, and scanning services. It is designed for acquisition, analysis, edit, review, report and storage of all ECG and multi-parameter data. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), acute MI, ventricular hypertrophy, abnormal ST-T changes, lethal arrhythmias, and common rhythm abnormalities. TM eCloud ECG Analysis System can analyze recordings performed on newborns, children, and adults. TM eCloud ECG Analysis System’s interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG that may be detected. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG.

Source page: https://510kreport.com/device/K142349
Methodology: https://510kreport.com/methodology