ClearanceBrief
510(k) K183046 ยท JAK System, X-Ray, Tomography, Computed

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

ApplicantCanon Medical Systems Corporation, Otawara-Shi, JP
DecisionSubstantially Equivalent, Jun 12, 2019
ReceivedNov 2, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K183046

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.