510(k) K254205

Zenition 30 by Philips Medical Systems Nederland B.V. — Product Code OWB

K254205 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Zenition 30". The FDA issued a decision of Substantially Equivalent on August 7, 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 Nederland B.V. has at least 10 other 510(k) clearances on record.