# K091789: Carto RMT EP Navigation System V8

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Oct 1, 2009 after 106 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: 1 generation back to K060047 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060047: Carto RMT EP Navigation System V8, Biosense Webster, Inc. (2006) Summary page 1.

## Indications for use
The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping. The CARTO RMT System v8 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. The CARTO RMT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and NIOBE 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.1 Tesla. Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWlKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTO™ XP capabilities. CARTO RMT System v8 includes the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.

Source page: https://510kreport.com/device/K091789
Methodology: https://510kreport.com/methodology