510(k) Report

Devices descending from K121329

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+1K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+1K132171AixplorerSupersonic Imagine201364—
+1K132274AixplorerSupersonic Imagine2013312—
+1K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+2K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+2K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+2K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+2K161999AixplorerSupersonic Imagine201620—
+2K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+2K150239FibroScanEchosens201525—
+2K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+2K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+2K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+2K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+2K142100AixplorerSupersonic Imagine201463—
+2K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+2K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+2K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+3K260748ES-SeriesE-Scopics20260—
+3K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+3K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+3K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+3K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+3K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+3K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+3K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+3K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+3K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+3K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+3K1619555D ViewerSamsung Medison Co., Ltd.20163—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+3K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+3K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+3K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+3K152195Logiq S8GE Healthcare201557—
+3K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+3K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+3K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+3K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+3K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+4K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+4K2301796440 MyLabX90Esaote, S.p.A.202341
+4K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+4K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+4K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+4K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K200655FibroScan® 630Echosens20200—
+4K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+4K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+4K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201920—
+4K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K191115RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201923—
+4K190444HERA I10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K1808835D ViewerSamsung Medison Co., Ltd.20180—
+4K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+4K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+4K1725133D EchoJointvue, LLC20171—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+4K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K170445Logiq S8GE Healthcare2017191
+4K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+4K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+4K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+4K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301