# K042493: Ensite System, Model EE3000

- Pathway: 510(k) (Special)
- Applicant: Endocardial Solutions, Inc.
- Decided: Oct 15, 2004 after 31 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: 3 generations back to K001437 (2000). 3 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030129: Modification to Ensite 3000 System, Model EE3000, Endocardial Solutions, Inc. (2003) Summary page 1.

## Most influential descendants
- K060954: Modification to Ensite System, Model EE3000 (2006), 51 descendants of its own
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01) (2007), 47 descendants of its own
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own
- K093455: Carto 3 Version 1.05 EP Navigation System and Accessories (2009), 34 descendants of its own
- K103746: Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) (2011), 33 descendants of its own

## Indications for use
The EnSite System is indicated for patients for whom electrophysiology studies are indicated. When used with the EnSite® Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR When used with the EnSite NavXTM Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology catheters in the heart.

Source page: https://510kreport.com/device/K042493
Methodology: https://510kreport.com/methodology