# K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: May 7, 2012 after 74 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001437 (2000). 21 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112007: Carto 3 EP Navigation System, Version 2.2, Biosense Webster, Inc. (2011) Summary page 1.
- K070240: Carto XP EP Navigation System, Version 9, Biosense Webster, Inc. (2007) Summary page 1.
- K060967: Niobe Magnetic Navigation System W/Navigant Workstation, Stereotaxis, Inc. (2006) Summary page 1.

## Most influential descendants
- K133916: Carto 3 EP Navigation System, Version 4.2 (2014), 27 descendants of its own
- K170600: CARTO 3 EP Navigation System, Version 6.0 and Accessories (2017), 20 descendants of its own
- K180238: CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (2018), 19 descendants of its own
- K191660: CARTO 3 EP Navigation System, Version 7.1 and Accessories (2019), 16 descendants of its own
- K200484: CARTO® 3 EP Navigation System with Signal Processing Unit (2020), 15 descendants of its own

## Recalls of this device
- Feb 12, 2014 · Class II · Z-1045-2014: Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural config
- Mar 5, 2013 · Class II · Z-1023-2013: Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by 

## Indications for use
The CARTO® 3 System V3.0 is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be displayed in real time on the system's display screen. The CARTO® 3 System V3.0 is also intended to support EP procedures, maintaining CARTO® System capabilities in the presence of a high metallic environment and magnetic field strengths up to 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 System V3.0 includes CARTOMERGE® PLUS Module functionality to import, register and merge CT or MRI structural images with CARTO® Map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND® image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. A fluoro background capability enables visualization of X-ray images as reference to the CARTO® Maps images and catheters. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Source page: https://510kreport.com/device/K120550
Methodology: https://510kreport.com/methodology