510(k) Report

Devices descending from K161567

4 later devices reach SIGNA Voyager through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+1K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+2K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+2K222259NEONA 1.5T MRI SystemTime Medical Limited20230—