510(k) K251827

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

K251827 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 October 24, 2025. 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.