# K042681: Carto RMT EP Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Sep 29, 2005 after 365 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
No predicates in its family tree.
34 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CARTO™ XP QwiKMAP EP Navigation System: named in the summary without a submission number

## Most influential descendants
- K063277: Mapmate (2006), 33 descendants of its own
- K092810: EP-Workmate System, Version 4.2 (2009), 32 descendants of its own
- K132073: EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module (2013), 31 descendants of its own
- K151911: WorkMate Claris System, WorkMate Claris System Display Plus (2015), 30 descendants of its own
- K160218: AutoMark Module (2016), 28 descendants of its own

## Indications for use
The intended use of the CARTO™ RMT mapping system is catheter-based atrial and ventricular mapping. The CARTO XP RMT 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 on the Stereotaxis Magnetic Navigation System in real time on the display screen. The CARTO™ RMT System is intended to support EP procedures in tihe presence of the high metallic environment created by the Stereotaxis Magnetic Navigation System, as well as in a regular lEP lab.

Source page: https://510kreport.com/device/K042681
Methodology: https://510kreport.com/methodology