FDA cleared the Zenition 30 from Philips Medical Systems Nederland B.V. on Aug 7, 2026 under K254205, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.
FDA logged the submission as received on Dec 29, 2025. The decision came 221 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Philips Medical Systems Nederland B.V. has 8 other decisions in the tracker over the last 12 months: K262330 (dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T), K262294 (dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T), K260207 (Multimodality Simulation Workspace (MM Sim) (v1.0.0)), K253614 (EchoNavigator R5.0).