510(k) Report

Devices descending from K052978

8 later devices reach GE 1.5T Signa Hde MR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+2K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+2K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+3K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+3K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+4K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+4K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+5K250379SIGNA Prime EliteGe Medical Systems, LLC20250—