# K121638: ST80I Stress Test System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Jul 18, 2012 after 44 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
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 V6.6 Cardiac Testing System: named in the summary without a submission number
- (no number) CS V6.6 Cardiac Testing System: named in the summary without a submission number

## Indications for use
The Philips STS0i Stress Test System 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 of cardiovascular disease. The Philips ST8Oi Stress Test System is not intended to be used as a physiological monitor.

Source page: https://510kreport.com/device/K121638
Methodology: https://510kreport.com/methodology