# K042148: Heart Rate Turbulence Analysis Technologies

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Syst. Information Technologies
- Decided: Dec 3, 2004 after 116 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
Longest line of descent: 2 generations back to K922171 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991786: Mars Unity Workstation with Heart Rate Variability (HRV) Option, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Indications for use
The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

Source page: https://510kreport.com/device/K042148
Methodology: https://510kreport.com/methodology