# K102507: Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia Detector

- Pathway: 510(k) (Abbreviated)
- Applicant: Tz Medical, Inc.
- Decided: Jun 13, 2011 after 285 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K882803 (1988). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005, Cardionet, Inc. (2007) Summary page 1.
- K100155: Truvue Wireless Ambulatory Ecg Monitoring System, Biomedical Systems Corp. (2010) Summary page 1.

## Indications for use
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RE Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional. Patients include, but are not limited to, those requiring monitoring for a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy, b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, b) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms. Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation). Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral schemnia, possibly secondary to atrial fibrillation or flutter. Data from this device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes. Contra ind ications: Patients with potentially life-threatening arrhythmias who require inpatient monitoring. Patients who the attending physician thinks should be hospitalized. Note: The Aera CT system does not provide interpretive or diagnostic statements. Interpretation and diagnosis is the sponsibility of a trained healthcare professional or physician.

Source page: https://510kreport.com/device/K102507
Methodology: https://510kreport.com/methodology