# K151598: VesselNavigator Rel. 1.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 17, 2015 after 66 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: 6 generations back to K913770 (1991). 17 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121772: Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1, Philips Medical Systems Nederland B.V. (2013) Summary page 6.

## Most influential descendants
- K160088: Cydar EV (2016), 7 descendants of its own
- K171829: EndoNaut (2017), 3 descendants of its own
- K212383: EndoNaut (2021), 2 descendants of its own
- K222070: EndoNaut (2022), 1 descendant of its own
- K212442: Cydar EV (Series B) and Cydar EV Maps (2021), 1 descendant of its own

## Indications for use
VesselNavigator provides image guidance by superimposing live fluoroscopic images on a 3D volume of the vessel anatomy to assist in catheter maneuvering and device placement. VesselNavigator is intended to assist in the treatment of endovascular diseases during procedures such as (but not limited to) AAA, TAA, carotid stenting, iliac interventions.

Source page: https://510kreport.com/device/K151598
Methodology: https://510kreport.com/methodology