510(k) Report

Devices descending from K103327

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+1K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+1K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+2K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+2K200327EvrySynaptive Medical, Inc.20201—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+2K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+3K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+3K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+3K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+3K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+4K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K162722HyperSenseGe Medical Systems, LLC20170—
+4K161567SIGNA VoyagerGE Healthcare201644
+4K161397MAGiCGe Medical Systems, LLC20161—
+4K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+4K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+5K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+5K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+5K162943SyMRISyntheticmr AB20170—
+5K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+5K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+5K160621SIGNAPioneerGE Healthcare201695
+5K153003SIGNA PioneerGE Healthcare201505
+6K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+6K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+6K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+6K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+6K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+6K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+6K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+6K171128SIGNA PremierGe Medical Systems, LLC2017118
+7K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+7K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+7K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+7K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+7K183231SIGNA PremierGe Medical Systems, LLC2019107
+8K243667Sonic DLGe Medical Systems, LLC20250—
+8K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+9K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+9K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+9K241242Signa MagnusGe Medical Systems, LLC20240—
+9K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+9K201615Signa 7.0TGe Medical Systems, LLC202011
+10K253808AIR Recon DLGE Medical Systems20260—
+10K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+10K252379AIR Recon DLGe Medical Systems, LLC20250—
+10K211118Signa 7.0TGe Medical Systems, LLC202101