# K023380: T-Wave Altermans (Twa) Algorithm Option

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Dec 3, 2002 after 56 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: 3 generations back to K903644 (1991). 5 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991014: Case 8000 Exercise Testing System, General Electric Medical Systems Information Techn (1999) Summary page 1.

## Most influential descendants
- K031561: Cardiosoft/Case Cardiac Testing System (2003), 30 descendants of its own
- K092010: PC Ecg, Model SE-1010 (2009), 18 descendants of its own
- K102854: PC ECG (2010), 13 descendants of its own
- K131819: PC ECG (2013), 12 descendants of its own
- K152427: PC ECG (2016), 11 descendants of its own

## Indications for use
The T-Wave Attemans (TWA) Algorithm Option is to be used in a hospital, doctor's office, or clinic environment by competent health care professionals for recording ST-T wave morphology fluctuations for patients who are undergoing Cardiovascular disease testing. The T-Wave alternans analysis is intended to provide only the measurements of the fluctuations of the ST-T-waves. The T-Wave alternans measurements produced by the T-Wave Alternans analysis are intended to be used by qualified personnel in evaluating the patient in conjunction with the patients clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment. No interpretation is generated.

Source page: https://510kreport.com/device/K023380
Methodology: https://510kreport.com/methodology