510(k) Report

Devices descending from K891689

901 later devices reach Mipron/Umipron through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+11K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+11K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+11K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+11K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+11K120741Voluson S6, Voluson S8GE Healthcare2012295—
+11K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+12K262390BoneXpertVisiana20260—
+12K251417ReVISION 2Argus Cognitive, Inc.20260—
+12K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+12K250914MediAI-BACrescom Co., Ltd.20250—
+12K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+12K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+12K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+12K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+12K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+12K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+12K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+12K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+12K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+12K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+12K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+12K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+12K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+12K212376Caas QardiaPie Medical Imaging BV20220—
+12K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+12K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+12K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+12K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+12K2116563D Echo v1.1Jointvue, LLC20210—
+12K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+12K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+12K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+12K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+12K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+12K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+12K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+12K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+12K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+12K200655FibroScan® 630Echosens20200—
+12K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+12K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+12K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+12K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+12K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+12K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+12K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+12K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+12K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+12K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+12K192152DC-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—
+12K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+12K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+12K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+12K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+12K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+12K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+12K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+12K190206DC-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—
+12K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+12K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+12K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+12K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+12K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+12K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+12K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+12K173569Ultrasound System 1300Bk Medical Aps20181—
+12K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+12K172860Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+12K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+12K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+12K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+12K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+12K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+12K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+12K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+12K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+12K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+12K170445Logiq S8GE Healthcare2017191
+12K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+12K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+12K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+12K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+12K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+12K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+12K160357TrinityKoelis20161—
+12K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+12K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+12K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+12K160524FibroScan 530 CompactEchosens201641—
+12K160182LOGIQ S7 ExpertGE Healthcare2016361
+12K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+12K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+12K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+12K143452Logiq P9, Logiq P7GE Healthcare2015131—