# K142273: EmboGuide

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Jan 30, 2015 after 168 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.
1 later device descends from it; 1 cites it directly.
0 of 19 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 4.

## Most influential descendants
- K182601: Vitrea Software Package, VSTP-001A (2018), 0 descendants of its own

## Indications for use
EmboGuide is a post processing software medical device intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure. It provides real time overlay of 3D rotational angiography images on live 2D X-ray images of the same anatomy to support device/catheter guidance.

Source page: https://510kreport.com/device/K142273
Methodology: https://510kreport.com/methodology