510(k) Report

Devices descending from K973767

1,087 later devices reach Harmonic Imaging with Contrast through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+7K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+7K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+7K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+7K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+7K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+7K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+7K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+7K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+7K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+7K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+7K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+7K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+7K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+7K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+7K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+7K143601U-LiteSonoscanner Sarl20153—
+7K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+7K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+7K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+7K142100AixplorerSupersonic Imagine201463—
+7K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+7K141768Logiq V5/Logiq V3GE Healthcare201457—
+7K141675Voluson P6, Voluson P8GE Healthcare201414—
+7K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+7K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+7K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+7K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+7K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+7K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+7K132171AixplorerSupersonic Imagine201364—
+7K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+7K131158CorviewMarrek, Inc.20130—
+7K130779Lvivo EF SystemDiacardio, Ltd.201324—
+7K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+7K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+7K121329AixplorerSupersonic Imagine2012405—
+7K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+7K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+7K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+7K102041AixplorerSupersonic Imagine2010527—
+7K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+7K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+7K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+7K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+7K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+7K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+7K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006193—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K253452Accuro 3SRivanna Medical, Inc.20260—
+8K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K260748ES-SeriesE-Scopics20260—
+8K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K254021Accuro XVRivanna Medical, Inc.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+8K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+8K250120GECHONarnar, LLC20250—
+8K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+8K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+8K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+8K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—