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
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+7K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+7K171594AccuroRivanna Medical, LLC20173—
+7K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+7K1725133D EchoJointvue, LLC20171—
+7K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K170841BiopSee, Mobile USMedcom GmbH20170—
+7K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+7K170069AmCAD-UVAmcad Biomed Corporation20170—
+7K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+7K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+7K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+7K161960bk2300Bk Medical Aps20165—
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+7K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+7K160162Voluson P6, Voluson P8GE Healthcare201613—
+7K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+7K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+7K151709Hi-Light Diagnostic Ultrasound SystemsQingdao Hisense Medical Equipment Co., Ltd.20150—
+7K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+7K150580UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20150—
+7K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+7K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+7K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+7K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+7K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+7K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+7K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+7K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+7K140677MylabssognoEsaote, S.p.A.20140—
+7K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+7K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+7K133277XARIO 100Toshibamedical Systems Corporation20142—
+7K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+7K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+7K132274AixplorerSupersonic Imagine2013312—
+7K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+7K131158CorviewMarrek, Inc.20130—
+7K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+7K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+7K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+7K111142Echosoft (TM)Echometrix, LLC20120—
+7K112255AixplorerSupersonic Imagine2012525—
+7K121384MylabsognoEsaote, S.p.A.201211
+7K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+7K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+7K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+7K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+7K110688MylabgoldEsaote2011251
+7K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+7K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+7K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+7K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+8K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260748ES-SeriesE-Scopics20260—
+8K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+8K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+8K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K251963LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K252105Ligence HeartLigence Uab20250—
+8K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K243937Accuro 3SRivanna Medical, Inc.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+8K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+8K240676ULTIMUS Series Ultrasound Diagnostic SystemVinno Technology (Suzhou) Co.,Ltd20240—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K241430EchoMeasureIcardio.Ai20240—
+8K241029SpineUs™ SystemVerdure Imaging20240—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+8K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+8K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+8K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+8K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+8K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+8K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+8K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+8K232285U-Lite PROSonoscanner Sarl20240—