510(k) Report

Devices descending from K032182

631 later devices reach GE Logiq 7, Model 2354858 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+8K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+8K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+8K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+8K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+8K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+8K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+8K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+8K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+8K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+8K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+8K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+8K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+8K181783Logiq P9; Logiq P7GE Healthcare2018171
+8K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+8K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K180535Voluson P6 and Voluson P8GE Healthcare2018121
+8K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+8K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+8K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+8K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+8K133277XARIO 100Toshibamedical Systems Corporation20142—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+9K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+9K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+9K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+9K232381LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+9K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+9K231966Logiq E10GE Medical Systems Ultrasound and Primary Care Diagnostics20235—
+9K231989LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic,20235—
+9K223570SonoAir Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20230—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+9K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+9K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+9K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+9K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+9K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+9K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+9K213689Voluson P6, Voluson P8GE Healthcare20220—
+9K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+9K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+9K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+9K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+9K203114Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+9K202422Arietta 65Hitachi Healthcare Americas20200—
+9K201828Voluson SWIFT, Voluson SWIFT+GE Medical Systems Ultrasound and Primary Care Diagnostics202010—
+9K201693DC-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—
+9K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+9K191233Arietta 750Hitachi Healthcare Americas201901
+9K190248Arietta 50Hitachi Healthcare Americas20191—
+9K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+9K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+9K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+9K172256SoftVueDelphinus Medical Technologies20180—
+9K162372QT Ultrasound Breast Scanner-1Qt Ultrasound, LLC20174—
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+9K150949FibroScanEchosens201542—
+9K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+10K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+10K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—