ClearanceBrief
510(k) K180916 ยท LLZ System, Image Processing, Radiological

iNtuition-T1 Mapping and T2/T2* Mapping

ApplicantTerarecon,Inc., Foster City CA, US
DecisionSubstantially Equivalent, Sep 24, 2018
ReceivedApr 9, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180916

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.