# K070240: Carto XP EP Navigation System, Version 9

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: May 4, 2007 after 99 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: 4 generations back to K000248 (2000). 4 ancestors in all.
58 later devices descend from it; 4 cite it directly.
5 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042999: Carto XP EP Navigation System, Software Verison 8, Biosense Webster, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K112007: Carto 3 EP Navigation System, Version 2.2 (2011), 32 descendants of its own
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) (2012), 31 descendants of its own

## Indications for use
The intended use of the CARTO® XP EP Navigation System, Version 9 is catheter-based atrial and ventricular mapping. The CARTO® XP EP Navigation System, Version 9 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, impedance 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. CARTO® XP EP Navigation System, Version 9 includes the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real-time catheter navigation. CARTO® XP EP Navigation System, Version 9 also allows the integration of intracardiac echo (ICE) visualization to provide 3D combined maps.

Source page: https://510kreport.com/device/K070240
Methodology: https://510kreport.com/methodology