# K251827: Azurion R3.1

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems B.V.
- Decided: Oct 24, 2025 after 133 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: 17 generations back to K801623 (1980). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200917: Azurion R2.1, Philips Medical Systems Nederland B.V. (2020) Summary page 5.

## Most influential descendants
- K254186: Azurion R3.1 (2026), 0 descendants of its own

## 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/K251827
Methodology: https://510kreport.com/methodology