# K042999: Carto XP EP Navigation System, Software Verison 8

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Mar 21, 2005 after 140 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). 3 ancestors in all.
99 later devices descend from it; 3 cite it directly.
5 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020863: Carto XP and Qwikmap EP Navigation System, Biosense Webster, Inc. (2003) Summary page 5.
- (no number) Siemens Medical System syngo Multimodality Workstation: named in the summary without a submission number

## Most influential descendants
- 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
- K063277: Mapmate (2006), 33 descendants of its own

## Indications for use
The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping. The CARTO XP mapping 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, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen. The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.

Source page: https://510kreport.com/device/K042999
Methodology: https://510kreport.com/methodology