ClearanceBrief
510(k) K160315 ยท LLZ System, Image Processing, Radiological

I4 (Integrated Intelligent Imaging Informatics) system

ApplicantPhilips Medical Systems Nederland B.V., Best, NL
DecisionSubstantially Equivalent, Feb 19, 2016
ReceivedFeb 5, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K160315

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.