Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Azurion R3.1

K-Number: K254186 · 2026-01-16

ApplicantPhilips Medical Systems B.V.
Decision Date2026-01-16
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Azurion R3.1 is a medical device manufactured by Philips Medical Systems B.V.. It received FDA 510(k) clearance on 2026-01-16 under approval number K254186. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Azurion R3.1?

Azurion R3.1 is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Philips Medical Systems B.V.. The 510(k) number is K254186.

When was Azurion R3.1 approved by the FDA?

Azurion R3.1 received FDA 510(k) clearance on 2026-01-16, under approval number K254186.

What company makes Azurion R3.1?

Azurion R3.1 is manufactured by Philips Medical Systems B.V..

What is the FDA product code for Azurion R3.1?

The FDA product code for Azurion R3.1 is OWB.

Other Devices by Philips Medical Systems B.V.

K251827Azurion R3.1

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑