510(k) Report

Devices descending from K003931

1,004 later devices reach Vivid 7 with Sonopac, Model FB0008XX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+7K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+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—
+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
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260748ES-SeriesE-Scopics20260—
+8K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+8K252105Ligence HeartLigence Uab20250—
+8K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K251342EchoPAC Software Only / EchoPAC Plug-inGE 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—
+8K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K241430EchoMeasureIcardio.Ai20240—
+8K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+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—
+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—
+8K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+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—
+8K232285U-Lite PROSonoscanner Sarl20240—
+8K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+8K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+8K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+8K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+8K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+8K222406Clarius AIClarius Mobile Health Corp.20233—
+8K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+8K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+8K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+8K220848Venue FitGE Medical Systems202241
+8K220800Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202232
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+8K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+8K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+8K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—