510(k) Report

Devices descending from K033196

990 later devices reach Sonoline Antares with Clarify VE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+7K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K170445Logiq S8GE Healthcare2017191
+7K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+7K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K160357TrinityKoelis20161—
+7K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+7K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+7K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+7K160524FibroScan 530 CompactEchosens201641—
+7K160182LOGIQ S7 ExpertGE Healthcare2016361
+7K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+7K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+7K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+7K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+7K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+7K143452Logiq P9, Logiq P7GE Healthcare2015131—
+7K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+7K141639Voluson S6, Voluson S8GE Healthcare2014151—
+7K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+7K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+7K133533Logiq EGE Healthcare2014149—
+7K133034Logiq F SeriesGE Healthcare2014155—
+7K133431VENUE 50GE Healthcare201360—
+7K131937Voluson I/EGE Healthcare201335—
+7K131158CorviewMarrek, Inc.20130—
+7K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+7K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+7K1311184D VIEWGE Healthcare20131—
+7K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+7K122387Voluson P6, Voluson P8GE Healthcare2012201—
+7K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+7K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+7K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+8K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+8K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+8K252105Ligence HeartLigence Uab20250—
+8K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250670EchoConfidence (USA)Mycardium AI Limited20250—
+8K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K241430EchoMeasureIcardio.Ai20240—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+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—
+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—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+8K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K231764Ultrasound System 1300Bk Medical Aps202301
+8K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+8K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+8K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+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—
+8K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+8K222441Ultrasound System 2300Bk Medical Aps20221—
+8K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+8K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+8K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+8K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+8K212012Follicle ClarityCycle Clarity20221—
+8K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+8K213102ES1 SystemE-Scopics20223—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+8K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+8K212100KosmosEchoNous, Inc.202101
+8K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+8K212035FibroScan 230Echosens20215—