# K020863: Carto XP and Qwikmap EP Navigation System

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Jan 9, 2003 after 297 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 K000248 (2000). 2 ancestors in all.
101 later devices descend from it; 3 cite it directly.
5 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013083: Carto XP EP Navigation System, Biosense Webster, Inc. (2001)

## Most influential descendants
- K042999: Carto XP EP Navigation System, Software Verison 8 (2005), 99 descendants of its own
- K070240: Carto XP EP Navigation System, Version 9 (2007), 58 descendants of its own
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own
- K093455: Carto 3 Version 1.05 EP Navigation System and Accessories (2009), 34 descendants of its own
- K103746: Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) (2011), 33 descendants of its own

## Indications for use
The intended use of the CARTOXP EP Navigation System is catheter-based atrial and ventricular mapping. The CARTOXP EP Navigation System 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 and cardiac impedance 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/K020863
Methodology: https://510kreport.com/methodology