# K140138: Heartnavigator Release 2.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jun 10, 2014 after 139 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: 10 generations back to K801623 (1980). 94 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 97 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130638: Alluraclarity Xper FD Series X-Ray System, Philips Medical Systems Nederland B.V. (2013) Summary page 2.
- K111245: Heartnavigator Release 1, Philips Medical Systems Nederland B.V. (2011) Summary page 2.

## Most influential descendants
- K243884: Tavipilot (2025), 0 descendants of its own
- K142126: EP Navigator Rel. 5.0 (2014), 0 descendants of its own

## Indications for use
HeartNavigator is a tool to assist the user with the treatment of structural heart diseases using minimal invasive interventional techniques. In addition to the conventional live fluoroscopy it provides the user with tools to plan and guide the procedure using 3D image data.

Source page: https://510kreport.com/device/K140138
Methodology: https://510kreport.com/methodology