510(k) Report

Devices descending from K013636

100 later devices reach Signa Infinity MR System with Excite Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC200499Class I
+2K133848Rthawk, Rthawk, or Heartvista Workstation with RthawkHeartvista, Inc.20146—
+2K052293GE 1.5T and 3.0T Signa HDX MR SystemGe Medical Systems, LLC20059021
+2K043262GE Signa Excite MR Surgical OptionGE Healthcare200502
+3K142997RTHawk, HeartVista Workstation with RTHawkHeartvista, Inc.20145—
+3K1216761.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC2012510
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K083147Discovery MR450Ge Medical Systems, LLC20086910
+3K081916GE Signa MR Oncology PackageGe Medical Systems, LLC20083—
+3K081028Signa 3.0T MR750 SystemGe Medical Systems, LLC20087011
+3K072998Ideal Software Option for GE MR ScannersGe Medical Systems, LLC20078—
+3K052978GE 1.5T Signa Hde MR SystemGe Medical Systems, LLC200585
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K200327EvrySynaptive Medical, Inc.20201—
+4K153740RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20164—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+4K131241SWIPPhilips Medical Systems Nederland B.V.20135—
+4K103327Discovery MR750W 3.0TGe Healthcare Japan Corporation2011526
+4K103411Ideal IQ Software OptionGE Medical Systems20115—
+4K103330Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201176
+4K102344Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR SystemsPhilips Medical Systems Nederland B.V.20101—
+4K102155MR Radiation Oncology OptionsGe Medical Systems, LLC20102—
+4K0929253D ASLGe Medical Systems, LLC20100—
+4K091536Optima MR450WGe Medical Systems, LLC2009598
+5K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+5K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+5K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+5K210415QSM software, QSMetricMedimagemetric, LLC20210—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K173224Spin-SwiSpintech, Inc.20183—
+5K170090RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20173—
+5K143128mDIXON XDPhilips Medical Systems Nederlands B.V.20150—
+5K133526Mdixon-QuantPhilips Medical Systems Nederland B.V.20140—
+5K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd.20133—
+5K130115Discovery MR750W 3.0TGe Medical Systems, LLC2013431
+5K123417Brivo MR355, Optima MR360Ge Hangwei Medical Systems Co., Ltd.201356
+5K123091Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TImris, Inc.20120—
+5K121997Imris Oncology PackageImris, Inc.20120—
+5K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+5K113490Optima MR450WGe Medical Systems, LLC2012443
+5K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+6K231459HepaFatSmart (V2.0.0)Resonance Health Analysis Services Pty, Ltd.20230—
+6K2232031.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd.20230—
+6K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+6K210843STAGESpintech, Inc.20211—
+6K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd.20202—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K183274RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20192—
+6K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+6K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+6K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+6K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+7K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+7K223079StageSpintech, Inc.20220—
+7K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+7K213776LiverSmartResonance Health Analysis Services Pty, Ltd.20210—
+7K212233RTHawk, HeartVista Cardiac PackageHeartvista, Inc.20211—
+7K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+7K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+7K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+8K251029Vista OS, Vista AI Scan, RTHawkVista AI, Inc.20250—
+8K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+8K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+8K162722HyperSenseGe Medical Systems, LLC20170—
+8K161567SIGNA VoyagerGE Healthcare201644
+8K161397MAGiCGe Medical Systems, LLC20161—
+8K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+8K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+9K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+9K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+9K162943SyMRISyntheticmr AB20170—
+9K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+9K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+9K160621SIGNAPioneerGE Healthcare201695
+9K153003SIGNA PioneerGE Healthcare201505
+10K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+10K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+10K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+10K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+10K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+10K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+10K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+10K171128SIGNA PremierGe Medical Systems, LLC2017118
+11K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+11K232346Digital Expert Access with Remote ScanningGE Healthcare20230—
+11K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+11K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+11K183231SIGNA PremierGe Medical Systems, LLC2019107
+12K243667Sonic DLGe Medical Systems, LLC20250—
+12K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+13K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+13K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+13K241242Signa MagnusGe Medical Systems, LLC20240—
+13K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+13K201615Signa 7.0TGe Medical Systems, LLC202011
+14K253808AIR Recon DLGE Medical Systems20260—
+14K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+14K252379AIR Recon DLGe Medical Systems, LLC20250—
+14K211118Signa 7.0TGe Medical Systems, LLC202101