ClearanceBrief
510(k) K254205 ยท OWB Interventional Fluoroscopic X-Ray System

Zenition 30

ApplicantPhilips Medical Systems Nederland B.V., Best, NL
DecisionSubstantially Equivalent, Aug 7, 2026
ReceivedDec 29, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K254205

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.