510(k) Report

Devices descending from K103330

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+1K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+2K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+2K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+3K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+3K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+4K250379SIGNA Prime EliteGe Medical Systems, LLC20250—