# K254186: Azurion R3.1

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems B.V.
- Decided: Jan 16, 2026 after 24 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: 18 generations back to K801623 (1980). 59 ancestors in all.
No later device cites it as a predicate yet.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251827: Azurion R3.1, Philips Medical Systems B.V. (2025) Summary page 5.

## Indications for use
The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: • Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedures. • Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: • The Azurion series can be used in a hybrid Operating Room. • The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. Patient Population: All human patients of all ages. Patient weight is limited to the specification of the patient table.

Source page: https://510kreport.com/device/K254186
Methodology: https://510kreport.com/methodology