ClearanceBrief
510(k) K243680 ยท LLZ System, Image Processing, Radiological

Neurovascular Insight V1.0

ApplicantOlea Medical S.A.S., La Ciotat, FR
DecisionSubstantially Equivalent, Aug 25, 2025
ReceivedNov 29, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243680

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.