510(k) Report

Devices descending from K160621

9 later devices reach SIGNAPioneer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+1K161567SIGNA VoyagerGE Healthcare201644
+2K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+2K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+2K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+2K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+3K243667Sonic DLGe Medical Systems, LLC20250—
+3K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+3K222259NEONA 1.5T MRI SystemTime Medical Limited20230—