Cleared Special

Azurion R3.1

K254186 · Philips Medical Systems B.V. · Radiology

Jan 2026

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K254186 is an FDA 510(k) clearance for the Azurion R3.1, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Philips Medical Systems B.V. (Best, NL). The FDA issued a Cleared decision on January 16, 2026, 24 days after receiving the submission on December 23, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K254186 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2025
Decision Date	January 16, 2026
Days to Decision	24 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy