510(k) Report

Devices descending from K143345

15 later devices reach SIGNA Pioneer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+1K160621SIGNAPioneerGE Healthcare201695
+1K153003SIGNA PioneerGE Healthcare201505
+2K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+2K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+2K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+2K161567SIGNA VoyagerGE Healthcare201644
+3K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+3K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+3K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+3K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+3K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+4K243667Sonic DLGe Medical Systems, LLC20250—
+4K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+4K222259NEONA 1.5T MRI SystemTime Medical Limited20230—