# K093566: Carto XP EP Navigation System, Version 10

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 18, 2010 after 212 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: 7 generations back to K001437 (2000). 15 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070240: Carto XP EP Navigation System, Version 9, Biosense Webster, Inc. (2007) Summary page 1.
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories, Biosense Webster, Inc. (2009) Summary page 1.

## Most influential descendants
- K201298: VX1 (2020), 8 descendants of its own
- K223516: VX1+ (2023), 4 descendants of its own
- K132782: CARTO3 EP Navigation System, Version 3.2 (2014), 4 descendants of its own
- K162793: RHYTHMIA HDx Mapping System (2017), 3 descendants of its own
- K232616: Volta AF-Xplorer (2023), 2 descendants of its own

## Indications for use
The intended use of the CARTO® XP System With CARTOXPRESSTM Module (V10) is catheter-based atrial and ventricular mapping. The CARTO® XP System With CARTOXPRESSTM Module (V10) 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 system display screen. CARTO XP System with CARTOXPRESSTM Module (V10) 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 System with CARTOXPRESSTM Module (V10) also allows the integration of intracardiac echo (ICE) 2D images to provide 3D combined maps. CARTO® XP System with CARTOXPRESSTM Module (V10) includes Fast Anatomical Mapping (FAM) that is a method for quick creation of cardiac anatomical volumes using catheters with magnetic location sensors, supports the LASSO® NAV Catheter with location sensors, displays Complex Fractionated Atrial Electrograms (CFAE), and adds Pace-Mapping Software (PaSo) ECG signal correlation tool.

Source page: https://510kreport.com/device/K093566
Methodology: https://510kreport.com/methodology