510(k) Report

Devices descending from K123417

5 later devices reach Brivo MR355, Optima MR360 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+1K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+2K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+2K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+3K250379SIGNA Prime EliteGe Medical Systems, LLC20250—