510(k) Report

Devices descending from K132274

312 later devices reach Aixplorer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+1K161999AixplorerSupersonic Imagine201620—
+1K150239FibroScanEchosens201525—
+1K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+1K142100AixplorerSupersonic Imagine201463—
+1K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+2K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+2K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+2K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+2K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+2K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+2K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+2K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+2K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+2K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+2K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+2K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+2K1619555D ViewerSamsung Medison Co., Ltd.20163—
+2K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+2K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+2K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+2K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+2K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+2K152195Logiq S8GE Healthcare201557—
+2K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+2K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+2K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+3K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+3K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+3K200655FibroScan® 630Echosens20200—
+3K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+3K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+3K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+3K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+3K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+3K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+3K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+3K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+3K1808835D ViewerSamsung Medison Co., Ltd.20180—
+3K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+3K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+3K1725133D EchoJointvue, LLC20171—
+3K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+3K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+3K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+3K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+3K170445Logiq S8GE Healthcare2017191
+3K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+3K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+3K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+3K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+3K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+3K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+3K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+3K160182LOGIQ S7 ExpertGE Healthcare2016361
+4K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K2301796440 MyLabX90Esaote, S.p.A.202341
+4K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens20231—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K213102ES1 SystemE-Scopics20223—
+4K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+4K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+4K212035FibroScan 230Echosens20215—
+4K2116563D Echo v1.1Jointvue, LLC20210—
+4K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+4K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+4K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+4K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+4K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+4K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+4K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+4K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+4K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+4K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+4K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+4K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+4K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+4K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K173555Logiq E10GE Healthcare2017382
+4K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203