510(k) Report

Devices descending from K031663

1,003 later devices reach GE Vivid 7, Model FC0003XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+1K081921GE Vivid E9 UltrasoundGeneral Electric Co.2008579—
+1K071503System, Tomography, Computed EmissionSyntermed, Inc.20075—
+1K060542GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co.20066891
+1K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+1K041552GE Vivid 7 BT04General Electric Co.2004996—
+2K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+2K152195Logiq S8GE Healthcare201557—
+2K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+2K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+2K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+2K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+2K130902Emory Cardiac Toolbox 3.2Syntermed, Inc.20130—
+2K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+2K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20122531
+2K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102595Medistim Veriqc SystemMedi-Stim Asa201001
+2K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+2K101149GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS2010350—
+2K101324GE Echopac Model BT10Ge Vingmed Ultrasound AS2010172—
+2K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+2K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+2K072952GE EchopacGeneral Electric Co.2007173—
+2K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+2K051449GE Vivid 7 with or Without SuffixGE Medical Systems2005704—
+2K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+3K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+3K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+3K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+3K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+3K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+3K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+3K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+3K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+3K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+3K170445Logiq S8GE Healthcare2017191
+3K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+3K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+3K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K131527Logiq S8GE Healthcare2013219—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+3K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121762
+3K121062Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemGe Medical System Israel, Ltd.20121101
+3K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+3K120305Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or…Thinking Systems Corp.20120—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K120221GE EchopacGE Healthcare2012170—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+3K111582Logiq S8GE Healthcare20113673
+3K110943Logiq E9GE Healthcare20114722
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+3K103649Voluson S6, Voluson S8GE Healthcare2011296—
+3K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+3K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+3K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+3K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+3K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+3K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+3K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+3K080223Zura Tee SystemImacor, LLC20085831
+3K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+3K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+3K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+3K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+3K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+4K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+4K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+4K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+4K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+4K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+4K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+4K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K173555Logiq E10GE Healthcare2017382
+4K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—