# K091594: Heart-Exercise

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies GmbH
- Decided: Jul 29, 2009 after 57 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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: 5 generations back to K903644 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Indications for use
The HEART-Exercise is to be used in a hospital, doctor's office, or clinical environment by competent healthcare professionals for assessing exercise test results. The results of HEART-Exercise are intended to be used by qualified personnel in evaluating the patient in conjunction with the patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment, HEART-Exercise provides measurements, prognostic scores, and int'rpretive statements of the exercise test for which the physician renders his/her own opinion. HEART-Exercise does not offer a diagnostic opinion to the user. The Exercise'Test Interpretation (XTI)is restricted to adults (age > 18 years). The measurements apply to adults and children able to accomplish an exercise test.

Source page: https://510kreport.com/device/K091594
Methodology: https://510kreport.com/methodology