510(k) K254186

Azurion R3.1 by Philips Medical Systems B.V. — Product Code OWB

K254186 is an FDA 510(k) premarket notification submitted by Philips Medical Systems B.V. for the device "Azurion R3.1". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Philips Medical Systems B.V. has at least 10 other 510(k) clearances on record.