# K132782: CARTO3 EP Navigation System, Version 3.2

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jan 24, 2014 after 140 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001437 (2000). 23 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad), Biosense Webster, Inc. (2012) Summary page 2.
- K093566: Carto XP EP Navigation System, Version 10, Biosense Webster, Inc. (2010) Summary page 1.

## Most influential descendants
- K162793: RHYTHMIA HDx Mapping System (2017), 3 descendants of its own
- K173837: RHYTHMIA HDx Mapping System (with software Version 2.0) (2018), 2 descendants of its own
- K192438: Rhythmia HDxTM Mapping System (2019), 1 descendant of its own
- K241227: RHYTHMIA HDx™ Mapping System (2024), 0 descendants of its own

## Recalls of this device
- Aug 15, 2016 · Class II · Z-2776-2016: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical S

## Indications for use
The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Source page: https://510kreport.com/device/K132782
Methodology: https://510kreport.com/methodology