510(k) Report

Devices descending from K130115

43 later devices reach Discovery MR750W 3.0T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+2K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+2K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+3K162722HyperSenseGe Medical Systems, LLC20170—
+3K161567SIGNA VoyagerGE Healthcare201644
+3K161397MAGiCGe Medical Systems, LLC20161—
+3K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+3K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+3K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+4K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+4K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+4K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+4K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+4K162943SyMRISyntheticmr AB20170—
+4K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+4K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+4K160621SIGNAPioneerGE Healthcare201695
+4K153003SIGNA PioneerGE Healthcare201505
+5K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+5K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+5K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+5K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+5K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+5K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+5K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+5K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+5K171128SIGNA PremierGe Medical Systems, LLC2017118
+6K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+6K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+6K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+6K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+6K183231SIGNA PremierGe Medical Systems, LLC2019107
+7K243667Sonic DLGe Medical Systems, LLC20250—
+7K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+8K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+8K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+8K241242Signa MagnusGe Medical Systems, LLC20240—
+8K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+8K201615Signa 7.0TGe Medical Systems, LLC202011
+9K253808AIR Recon DLGE Medical Systems20260—
+9K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+9K252379AIR Recon DLGe Medical Systems, LLC20250—
+9K211118Signa 7.0TGe Medical Systems, LLC202101