# K120770: QT Guard Plus Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Dec 6, 2012 after 267 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
Longest line of descent: 5 generations back to K842308 (1984). 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)
- K981024: QT Dispersion and T Wave Analysis Program (QT Guard Analysis System), Marquette Medical Systems, Inc. (1998) Summary page 1.
- K072502: Modification to: Muse Cardiology Information System, Ge Medical Systems Information Technologies (2007) Summary page 1.

## Indications for use
QT Guard Plus Analysis System is intended to be used in a hospital, clinic or research environment by competent health professionals. QT Guard Plus Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECGs for obtaining the measurement of QT interval dispersion and T wave complexity. QT Guard Plus Analysis System is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurement or diagnosis. The QT dispersion and T wave complexity measurements produced by QT Guard Plus Analysis System are intended to be used by qualified personnel in evaluating ECG data and the patient in conjunction with patient's clinical history, symptoms other diagnostic tests, as well as the professional's clinical judgment. QT Guard Plus Analysis System is intended for adult patient populations.

Source page: https://510kreport.com/device/K120770
Methodology: https://510kreport.com/methodology