510(k) Report

Devices descending from K083147

69 later devices reach Discovery MR450 through their predicates, nearest generation first.

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