ClearanceBrief
510(k) K252199 ยท LLZ System, Image Processing, Radiological

AGFA HealthCare Enterprise Imaging

ApplicantAgfa Healthcare N.V., Mortsel, BE
DecisionSubstantially Equivalent, Oct 15, 2025
ReceivedJul 14, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252199

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.