# K071818: Ensite Fusion Dynamic Registration Tool

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Dec 20, 2007 after 170 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: 6 generations back to K001437 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070902: Modification to: Ensite System, Model, EE3000, St Jude Medical (2007) Summary page 1.

## Indications for use
EnSite Fusion is indicated for registering the EnSite NavX navigation system to anatomic models, derived from CT scans, of the four individual cardiac chambers.

Source page: https://510kreport.com/device/K071818
Methodology: https://510kreport.com/methodology