510(k) Report

Devices descending from K973767

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+10K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+10K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+10K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+10K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K173569Ultrasound System 1300Bk Medical Aps20181—
+10K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+10K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+10K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K163505Arietta PrecisionHitachi, Ltd.20170—
+10K162583Aloka Lisendo 880Hitachi, Ltd.201602
+10K163020Xperius Ultrasound SystemPhilips Health Care201611
+10K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+10K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+10K160524FibroScan 530 CompactEchosens201641—
+10K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+10K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+10K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+11K262390BoneXpertVisiana20260—
+11K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+11K250914MediAI-BACrescom Co., Ltd.20250—
+11K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+11K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+11K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+11K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+11K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+11K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+11K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+11K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+11K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+11K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+11K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+11K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20232—
+11K231764Ultrasound System 1300Bk Medical Aps202301
+11K230365Sonio DetectSonio20237—
+11K230346Voluson SWIFT; Voluson SWIFT+Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC20231—
+11K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+11K223832Vivid S60N, Vivid S70NGe Medical System Ultrasound and Primary Care Diagnostics202312
+11K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+11K222441Ultrasound System 2300Bk Medical Aps20221—
+11K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+11K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+11K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+11K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K220882Vivid E80, Vivid E90, Vivid E95Ge Medical Systems Ultrasound And20222—
+11K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+11K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+11K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+11K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+11K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+11K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+11K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+11K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+11K201597Liver Incytes, Model 1005Sonic Incytes20204—
+11K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+11K190646QT Scanner 2000 Model AQt Ultrasound, LLC20192—
+11K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+11K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+11K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+11K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+11K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+11K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+11K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+11K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+11K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+11K172142FibroScan 430 Mini+Echosens20170—
+11K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+12K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+12K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+12K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+12K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+12K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+12K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…Wuhan United Imaging Healthcare Co.,Ltd20260—
+12K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+12K253370LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+12K253366LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics20262—
+12K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+12K251985Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20250—