# K053194: Noga XP Cardiac Navigation System with Qwikmap Software

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Mar 9, 2006 after 114 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 K000248 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000332: Noga Cardiac Navigation System, Biosense Webster, Inc. (2000) Summary page 1.
- K020863: Carto XP and Qwikmap EP Navigation System, Biosense Webster, Inc. (2003) Summary page 1.

## Indications for use
The intended use of the NOGATM XP Cardiac Navigation System with QwikMapTM Software is catheter-based cardiac mapping. The NOGATM XP Cardiac Navigation System with QwikMapTM Software allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps, cardiac dynamic maps, cardiac hemodynamic maps, and cardiac electromechanical maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

Source page: https://510kreport.com/device/K053194
Methodology: https://510kreport.com/methodology