ClearanceBrief
510(k) K163328 ยท MUE Full Field Digital, System, X-Ray, Mammographic

Planmed Clarity

ApplicantPlanmed OY, Helsinki, FI
DecisionSubstantially Equivalent, Dec 28, 2017
ReceivedNov 28, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163328

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.