510(k) Report

Devices descending from K003613

108 later devices reach 3.0.T Signa VH/I (T/R) Body Imaging Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023679Gore 3.0T Torso ArrayW. L. Gore & Associates, Inc.20020—
+1K022397Signa 3.0T Magnetic Resonance SystemGE Medical Systems20021041
+1K012970GE Signa Asset Imaging OptionGE Medical Systems20011—
+2K162403HyperBandGe Medical Systems, LLC20160—
+2K040444GE Signa 3.0T with Excite MR SystemGeneral Electric Co.20042Class I
+2K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co.2003100Class I
+3K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc.20080—
+3K052200Tem 3000 Head CoilMr Instruments, Inc.20050—
+3K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC200499Class I
+4K133848Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc.20146—
+4K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC20059021
+4K043262GE Signa Excite MR Surgical OptionGE Healthcare200502
+5K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc.20145—
+5K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+5K083421MR-Touch OptionGe Medical Systems, LLC20094—
+5K083147Discovery MR450Ge Medical Systems, LLC20086910
+5K081916GE Signa MR Oncology PackageGe Medical Systems, LLC20083—
+5K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC20087011
+5K072998Ideal Software Option for GE MR ScannersGe Medical Systems, LLC20078—
+5K052978GE 1.5T Signa Hde MR SystemGe Medical Systems, LLC200585
+6K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+6K200327EvrySynaptive Medical, Inc.20201—
+6K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20164—
+6K151212Ziostation2Qi Imaging, LLC20152—
+6K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+6K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+6K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+6K103411Ideal IQ Software OptionGE Medical Systems20115—
+6K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+6K102344Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR SystemsPhilips Medical Systems Nederland B.V.20101—
+6K102155MR Radiation Oncology OptionsGe Medical Systems, LLC20102—
+6K0929253D ASLGe Medical Systems, LLC20100—
+6K091536Optima MR450WGe Medical Systems, LLC2009598
+7K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+7K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+7K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+7K210415QSM software, QSMetricMedimagemetric, LLC20210—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K173224Spin-SwiSpintech, Inc.20183—
+7K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20173—
+7K143128mDIXON XDPhilips Medical Systems Nederlands B.V.20150—
+7K133526Mdixon-QuantPhilips Medical Systems Nederland B.V.20140—
+7K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+7K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+7K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+7K123091Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TImris, Inc.20120—
+7K121997Imris Oncology PackageImris, Inc.20120—
+7K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+7K113490Optima MR450WGe Medical Systems, LLC2012443
+7K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+8K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+8K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+8K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+8K210843STAGESpintech, Inc.20211—
+8K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20192—
+8K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+8K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+8K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+8K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+9K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+9K223079StageSpintech, Inc.20220—
+9K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+9K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+9K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20211—
+9K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+9K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+9K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+10K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc.20250—
+10K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+10K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+10K162722HyperSenseGe Medical Systems, LLC20170—
+10K161567SIGNA VoyagerGE Healthcare201644
+10K161397MAGiCGe Medical Systems, LLC20161—
+10K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+10K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+11K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+11K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+11K162943SyMRISyntheticmr AB20170—
+11K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+11K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+11K160621SIGNAPioneerGE Healthcare201695
+11K153003SIGNA PioneerGE Healthcare201505
+12K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+12K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+12K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+12K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+12K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+12K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+12K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+12K171128SIGNA PremierGe Medical Systems, LLC2017118
+13K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+13K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+13K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+13K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+13K183231SIGNA PremierGe Medical Systems, LLC2019107
+14K243667Sonic DLGe Medical Systems, LLC20250—
+14K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+15K253780SIGNA™ BoltGe Medical Systems, LLC20260—