510(k) Report

Devices descending from K003575

103 later devices reach Modification to 3.0T Signa VH/I Magnetic Resonance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co.2003100Class I
+1K012970GE Signa Asset Imaging OptionGE Medical Systems20011—
+2K162403HyperBandGe Medical Systems, LLC20160—
+2K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC200499Class I
+3K133848Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc.20146—
+3K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC20059021
+3K043262GE Signa Excite MR Surgical OptionGE Healthcare200502
+4K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc.20145—
+4K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K083147Discovery MR450Ge Medical Systems, LLC20086910
+4K081916GE Signa MR Oncology PackageGe Medical Systems, LLC20083—
+4K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC20087011
+4K072998Ideal Software Option for GE MR ScannersGe Medical Systems, LLC20078—
+4K052978GE 1.5T Signa Hde MR SystemGe Medical Systems, LLC200585
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K200327EvrySynaptive Medical, Inc.20201—
+5K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20164—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+5K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+5K103411Ideal IQ Software OptionGE Medical Systems20115—
+5K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+5K102344Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR SystemsPhilips Medical Systems Nederland B.V.20101—
+5K102155MR Radiation Oncology OptionsGe Medical Systems, LLC20102—
+5K0929253D ASLGe Medical Systems, LLC20100—
+5K091536Optima MR450WGe Medical Systems, LLC2009598
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K210415QSM software, QSMetricMedimagemetric, LLC20210—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K173224Spin-SwiSpintech, Inc.20183—
+6K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20173—
+6K143128mDIXON XDPhilips Medical Systems Nederlands B.V.20150—
+6K133526Mdixon-QuantPhilips Medical Systems Nederland B.V.20140—
+6K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+6K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+6K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+6K123091Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TImris, Inc.20120—
+6K121997Imris Oncology PackageImris, Inc.20120—
+6K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+6K113490Optima MR450WGe Medical Systems, LLC2012443
+6K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+7K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+7K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+7K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+7K210843STAGESpintech, Inc.20211—
+7K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+7K200315Ziostation2Ziosoft, Inc.20200—
+7K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20192—
+7K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+7K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+7K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+7K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+8K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+8K223079StageSpintech, Inc.20220—
+8K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+8K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+8K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20211—
+8K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+8K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+8K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+9K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc.20250—
+9K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+9K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+9K162722HyperSenseGe Medical Systems, LLC20170—
+9K161567SIGNA VoyagerGE Healthcare201644
+9K161397MAGiCGe Medical Systems, LLC20161—
+9K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+9K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+10K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+10K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+10K162943SyMRISyntheticmr AB20170—
+10K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+10K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+10K160621SIGNAPioneerGE Healthcare201695
+10K153003SIGNA PioneerGE Healthcare201505
+11K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+11K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+11K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+11K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+11K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+11K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+11K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+11K171128SIGNA PremierGe Medical Systems, LLC2017118
+12K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+12K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+12K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+12K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+12K183231SIGNA PremierGe Medical Systems, LLC2019107
+13K243667Sonic DLGe Medical Systems, LLC20250—
+13K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+14K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+14K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+14K241242Signa MagnusGe Medical Systems, LLC20240—
+14K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+14K201615Signa 7.0TGe Medical Systems, LLC202011
+15K253808AIR Recon DLGE Medical Systems20260—