510(k) Report

Devices descending from K112255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+1K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+1K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+1K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+1K132171AixplorerSupersonic Imagine201364—
+1K132274AixplorerSupersonic Imagine2013312—
+1K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+1K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+1K123806FibroscanEchosens201355—
+2K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+2K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+2K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+2K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+2K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+2K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+2K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+2K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+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—
+2K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+2K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+2K150949FibroScanEchosens201542—
+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
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K260748ES-SeriesE-Scopics20260—
+3K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+3K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+3K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+3K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+3K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+3K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+3K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+3K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+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—
+3K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+3K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+3K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+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—
+3K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+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—
+3K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+3K160524FibroScan 530 CompactEchosens201641—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+3K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+3K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+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—
+3K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+3K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+3K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+3K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+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—
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+4K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+4K2301796440 MyLabX90Esaote, S.p.A.202341
+4K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+4K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+4K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+4K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+4K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+4K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—