ClearanceBrief
510(k) K181345 ยท NFJ System, Image Management, Ophthalmic

Image Filing Software NAVIS-EX

ApplicantNidek Co., Ltd., Gamagori, JP
DecisionSubstantially Equivalent, Jul 19, 2018
ReceivedMay 21, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K181345

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.