510(k) Report

Devices descending from K143251

3 later devices reach SIGNA Creator, SIGNA Explorer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+1K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+2K250379SIGNA Prime EliteGe Medical Systems, LLC20250—