510(k) Report

Devices descending from K973767

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K180535Voluson P6 and Voluson P8GE Healthcare2018121
+9K172256SoftVueDelphinus Medical Technologies20180—
+9K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+9K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+9K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+9K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+9K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+9K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+9K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+9K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+9K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+9K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+9K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+9K161960bk2300Bk Medical Aps20165—
+9K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+9K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+9K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+9K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+9K150239FibroScanEchosens201525—
+9K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+9K150949FibroScanEchosens201542—
+9K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+9K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+9K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+9K140808Q-StationPhilips Ultrasound, Inc.201402
+9K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+9K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+9K123806FibroscanEchosens201355—
+9K123616Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20120—
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+10K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+10K252332FolliscanMim Fertility20260—
+10K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+10K252105Ligence HeartLigence Uab20250—
+10K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251456BrightHeart View ClassifierBrightheart20250—
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+10K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+10K241430EchoMeasureIcardio.Ai20240—
+10K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+10K242223SuperSonic HepaVuSupersonic Imagine20240—
+10K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K240053Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240206Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K234106Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202421
+10K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+10K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+10K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+10K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+10K232285U-Lite PROSonoscanner Sarl20240—
+10K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+10K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+10K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+10K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+10K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+10K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+10K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+10K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+10K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+10K213689Voluson P6, Voluson P8GE Healthcare20220—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+10K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K211488Logiq E10GE Healthcare202111—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+10K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—