# K981024: QT Dispersion and T Wave Analysis Program (QT Guard Analysis System)

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Oct 6, 1998 after 201 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
87 later devices descend from it; 2 cite it directly.
0 of 88 devices 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) Marquette 12SL Analysis Program: named in the summary without a submission number

## Most influential descendants
- K010949: 2010 Plus Holter for Windows (2001), 85 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own

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

Source page: https://510kreport.com/device/K981024
Methodology: https://510kreport.com/methodology