510(k) Report

Devices descending from K042540

882 later devices reach Philips IU22 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+1K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+1K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+1K120525Qlab Quantification SoftwarePhilips Healthcare Group201292—
+1K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+1K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+1K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+1K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+1K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+1K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006191—
+1K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+1K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A.200564—
+2K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+2K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+2K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+2K170069AmCAD-UVAmcad Biomed Corporation20170—
+2K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+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—
+2K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+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—
+2K142100AixplorerSupersonic Imagine201463—
+2K140808Q-StationPhilips Ultrasound, Inc.201402
+2K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+2K132171AixplorerSupersonic Imagine201364—
+2K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+2K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+2K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+2K111142Echosoft (TM)Echometrix, LLC20120—
+2K121329AixplorerSupersonic Imagine2012405—
+2K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+2K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+2K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+2K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+2K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+2K102041AixplorerSupersonic Imagine2010527—
+2K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+2K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+2K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+2K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+2K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+2K091680Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.200925—
+2K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+2K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K081873Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd.20083—
+2K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+2K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+2K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+2K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+2K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+2K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+2K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A.200560—
+3K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+3K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+3K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+3K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+3K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+3K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+3K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+3K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+3K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+3K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+3K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+3K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+3K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+3K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20171—
+3K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+3K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+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—
+3K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+3K161999AixplorerSupersonic Imagine201620—
+3K163020Xperius Ultrasound SystemPhilips Health Care201611
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+3K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+3K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+3K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+3K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794