ClearanceBrief
510(k) K180809 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Eclipse II

ApplicantCarestream Health, Inc., Rochester NY, US
DecisionSubstantially Equivalent, Jun 21, 2018
ReceivedMar 28, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K180809

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.