# K110463: Pcecg-1200 System with Modular Ecg Analysis System (Means)

- Pathway: 510(k) (Special)
- Applicant: Norav Medical, Ltd.
- Decided: Nov 10, 2011 after 266 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000404 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080141: PC Ecg 1200W System, Norav Medical, Ltd. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K081324: Candela Family of Q-Switched Alexandrite Lasers, Candela Corp. (2008). Our reading of the summary gave K081324, FDA’s number for Candela Family of Q-Switched Alexandrite Lasers (Candela Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Welch Allyn's CardioPerfect Workstation (CPWS) V 1.6.2 Software”. Kept off the family tree.

## Indications for use
ECG intended use: ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients: 1) suspected of cardiac abnormalities, or 2) in populations of patients at an age or period in which a routine baseline evaluation of EG characteristics are desired. 3) QT Analysis is useful in the assessment of long QT syndrome (LOTS). In some instances, LQTS can be corrected by pharmacologic therapy. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1 millisecond tolerance. The clinical significance of HRV measures should be determined by a physician. 5) The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician. Stress testing intended use: Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemnia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. Instress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the EGG. Exercise loads are determined by predefined protocols. The EG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in EGG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol. ST segment monitoring is intended as an aid in the evaluation of myocardial ischemnia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.

Source page: https://510kreport.com/device/K110463
Methodology: https://510kreport.com/methodology