510(k) Report

Devices descending from K093563

588 later devices reach IU22 Ultrasound System and Transducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+5K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+5K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+5K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+5K200655FibroScan® 630Echosens20200—
+5K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+5K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+5K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+5K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+5K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K192152DC-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—
+5K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+5K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+5K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+5K190206DC-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—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—
+5K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+5K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+5K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+5K181574UscanEchoNous, Inc.20180—
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+5K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+5K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+5K1725133D EchoJointvue, LLC20171—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+5K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+5K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+5K170445Logiq S8GE Healthcare2017191
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+5K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+5K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+5K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+5K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+5K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+5K160524FibroScan 530 CompactEchosens201641—
+5K160182LOGIQ S7 ExpertGE Healthcare2016361
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+6K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+6K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+6K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+6K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+6K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+6K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+6K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+6K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+6K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+6K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+6K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+6K213102ES1 SystemE-Scopics20223—
+6K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+6K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+6K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+6K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—