# K142126: EP Navigator Rel. 5.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Dec 9, 2014 after 127 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K801623 (1980). 96 ancestors in all.
No later device cites it as a predicate yet.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133292: Allura Xper FD; or Table, Philips Medical Systems Nederland B.V. (2014) Summary page 4.
- K101311: EP Navigator R3, Philips Medical Systems North America Co. (2010) Summary page 5.
- K140138: Heartnavigator Release 2.0, Philips Medical Systems Nederland B.V. (2014) Summary page 5.

## Indications for use
EP navigator is intended to provide navigation support for cardiovascular devices for heart thythm disorders, such as catheters and guidewires, by superimposing 3D cardiac anatomical image data, such as CT, MRI, or 3D rotational scan over intra-procedural X-ray images of the same anatomy.

Source page: https://510kreport.com/device/K142126
Methodology: https://510kreport.com/methodology