ClearanceBrief
510(k) K243446 ยท OWB Interventional Fluoroscopic X-Ray System

3DXR

ApplicantGE Medical Systems SCS, Buc, FR
DecisionSubstantially Equivalent, Feb 25, 2025
ReceivedNov 6, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243446

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.