510(k) Report

Devices descending from K023877

611 later devices reach Q Lab Quantification Software with Strain Rate Quantification Plug-in through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+1K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+2K161959ClearView cCADClearview Diagnostics, Inc.2016131
+2K142100AixplorerSupersonic Imagine201463—
+2K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+2K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+2K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+2K132171AixplorerSupersonic Imagine201364—
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+2K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+2K111142Echosoft (TM)Echometrix, LLC20120—
+2K121329AixplorerSupersonic Imagine2012405—
+2K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+2K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+2K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102041AixplorerSupersonic Imagine2010527—
+2K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+3K190442Koios DS for BreastKoios Medical, Inc.201912—
+3K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+3K161999AixplorerSupersonic Imagine201620—
+3K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+3K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+3K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+3K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+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—
+3K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+3K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+3K132274AixplorerSupersonic Imagine2013312—
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+3K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+3K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K112255AixplorerSupersonic Imagine2012525—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K212616Koios DSKoios Medical, Inc.20214—
+4K203555AmCAD-UTAmcad Biomed Corporation20212—
+4K201555EchoGo ProUltromics, Ltd.20206—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+4K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+4K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+4K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+4K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+4K163690DC-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—
+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—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K163020Xperius Ultrasound SystemPhilips Health Care201611
+4K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+4K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+4K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+4K1619555D ViewerSamsung Medison Co., Ltd.20163—
+4K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+4K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+4K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+4K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+4K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+4K150239FibroScanEchosens201525—
+4K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—