510(k) Report

Devices descending from K093563

588 later devices reach IU22 Ultrasound System and Transducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142100AixplorerSupersonic Imagine201463—
+1K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+1K132171AixplorerSupersonic Imagine201364—
+1K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+1K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+1K111142Echosoft (TM)Echometrix, LLC20120—
+1K121329AixplorerSupersonic Imagine2012405—
+1K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+1K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+1K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+1K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+1K102041AixplorerSupersonic Imagine2010527—
+2K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+2K161999AixplorerSupersonic Imagine201620—
+2K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+2K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+2K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+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—
+2K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+2K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+2K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+2K140808Q-StationPhilips Ultrasound, Inc.201402
+2K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+2K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+2K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+2K132274AixplorerSupersonic Imagine2013312—
+2K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+2K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+2K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+2K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+2K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+2K112255AixplorerSupersonic Imagine2012525—
+2K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+2K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+2K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+2K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+3K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+3K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+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—
+3K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+3K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+3K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+3K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+3K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+3K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+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—
+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—
+3K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+3K163020Xperius Ultrasound SystemPhilips Health Care201611
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+3K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+3K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+3K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+3K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+3K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+3K150239FibroScanEchosens201525—
+3K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+3K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+3K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+3K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+3K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+3K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+3K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+3K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+3K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+3K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+3K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+3K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+3K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+3K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+3K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733