ClearanceBrief
510(k) K161748 ยท JAK System, X-Ray, Tomography, Computed

SUPRIA w/guideShot Option

ApplicantHitachi Medical Systems America, Inc., Twinsburg OH, US
DecisionSubstantially Equivalent, Aug 17, 2016
ReceivedJun 24, 2016
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K161748

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.