# K112959: Calg-STR Exercise Ecg Analysis Algorithm

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Jan 26, 2012 after 114 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
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. The FDA summary names its predicate without a number.
- (no number) CASE Cardiac Testing System: named in the summary without a submission number
- (no number) CS Cardiac Testing System: named in the summary without a submission number

## Indications for use
The intended use of the CAlg-STR exercise ECG analysis algorithm is to analyze multi-channel ECG waveforms acquired from a patient and produce measurements such as heart rate, detect ventricular arrhythmias, form representative beats, and calculate ST segment deviation (elevation or depression) and ST slope for review by a trained physician or clinician in determining a diagnosis. The measurements should not be used as a sole means for determining a patient's diagnosis. The analysis algorithm is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms. The analysis algorithm is not intended to be used as a physiological monitor.

Source page: https://510kreport.com/device/K112959
Methodology: https://510kreport.com/methodology