510(k) Report

Devices descending from K030455

535 later devices reach Boris Platform Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+1K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+1K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20125322
+1K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+1K091804CX50 Version 2.0 Diagnostic Ultrasound System and TransducersPhilips Ultrasound, Inc.2009577
+1K083877Flying Diagnostic Ultrasound SystemNeusoft Medical Systems Co., Ltd.20090—
+2K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+2K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+2K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+2K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+2K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+2K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+2K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+2K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+2K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+2K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+2K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+2K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+2K140808Q-StationPhilips Ultrasound, Inc.201402
+2K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K112255AixplorerSupersonic Imagine2012525—
+2K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20115610
+2K102041AixplorerSupersonic Imagine2010527—
+3K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+3K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+3K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+3K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+3K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+3K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+3K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+3K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+3K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+3K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+3K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+3K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+3K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+3K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+3K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+3K163020Xperius Ultrasound SystemPhilips Health Care201611
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+3K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+3K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+3K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+3K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+3K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+3K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+3K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+3K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+3K132171AixplorerSupersonic Imagine201364—
+3K132274AixplorerSupersonic Imagine2013312—
+3K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+3K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+3K123806FibroscanEchosens201355—
+3K121329AixplorerSupersonic Imagine2012405—
+4K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+4K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+4K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+4K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+4K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+4K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+4K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+4K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+4K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+4K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+4K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+4K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+4K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+4K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+4K163443Interson USB Ultrasound SystemInterson Corporation20173—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161999AixplorerSupersonic Imagine201620—
+4K162549Lumify Ultrasound SystemPhilips Health Care2016436
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—