ClearanceBrief
510(k) K181415 ยท OWB Interventional Fluoroscopic X-Ray System

XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0

ApplicantCanon Medical Systems Corporation, Otawara-Shi, JP
DecisionSubstantially Equivalent, Sep 10, 2018
ReceivedMay 30, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181415

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.