510(k) Report

Devices descending from K081028

70 later devices reach Signa 3.0T MR750 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+1K083147Discovery MR450Ge Medical Systems, LLC20086910
+2K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+2K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+2K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+2K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+2K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+2K0929253D ASLGe Medical Systems, LLC20100—
+2K091536Optima MR450WGe Medical Systems, LLC2009598
+3K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+3K210415QSM software, QSMetricMedimagemetric, LLC20210—
+3K200327EvrySynaptive Medical, Inc.20201—
+3K173224Spin-SwiSpintech, Inc.20183—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+3K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+3K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+3K113490Optima MR450WGe Medical Systems, LLC2012443
+3K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+4K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+4K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+4K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+4K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+4K210843STAGESpintech, Inc.20211—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+4K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+4K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+4K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+5K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+5K223079StageSpintech, Inc.20220—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K162722HyperSenseGe Medical Systems, LLC20170—
+5K161567SIGNA VoyagerGE Healthcare201644
+5K161397MAGiCGe Medical Systems, LLC20161—
+5K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+5K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+5K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+6K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+6K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+6K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+6K162943SyMRISyntheticmr AB20170—
+6K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+6K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+6K160621SIGNAPioneerGE Healthcare201695
+6K153003SIGNA PioneerGE Healthcare201505
+7K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+7K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+7K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+7K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+7K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+7K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+7K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+7K171128SIGNA PremierGe Medical Systems, LLC2017118
+8K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+8K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+8K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+8K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+8K183231SIGNA PremierGe Medical Systems, LLC2019107
+9K243667Sonic DLGe Medical Systems, LLC20250—
+9K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+10K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+10K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+10K241242Signa MagnusGe Medical Systems, LLC20240—
+10K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+10K201615Signa 7.0TGe Medical Systems, LLC202011
+11K253808AIR Recon DLGE Medical Systems20260—
+11K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+11K252379AIR Recon DLGe Medical Systems, LLC20250—
+11K211118Signa 7.0TGe Medical Systems, LLC202101