ClearanceBrief
510(k) K170816 ยท LLZ System, Image Processing, Radiological

Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

ApplicantBrainlab AG, Munich, DE
DecisionSubstantially Equivalent, Sep 26, 2017
ReceivedMar 20, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K170816

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.