510(k) Report

Devices descending from K040227

908 later devices reach Qlab Quantification Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+1K103761Visualize: VascularThe Medipattern Corporation20110—
+1K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+1K033266Vascular Tools 5, Consisting of Brachial Analyzer 5, Carotid Analyzer 5, Vascular Imager…Medical Imaging Applications, LLC20041—
+1K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc.20048824
+2K202094Cardiovascular Suite 4.2.1Quipu S.R.L20220—
+2K161959ClearView cCADClearview Diagnostics, Inc.2016131
+2K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+2K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+2K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+2K120525Qlab Quantification SoftwarePhilips Healthcare Group201292—
+2K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+2K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+2K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+2K072258BI-Rads CompanionAlmen Laboratories, Inc.20080—
+2K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+2K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+2K060949DP-6600 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006191—
+2K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc.200615429
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+2K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A.200564—
+3K190442Koios DS for BreastKoios Medical, Inc.201912—
+3K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+3K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+3K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+3K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+3K170069AmCAD-UVAmcad Biomed Corporation20170—
+3K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+3K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+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
+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—
+3K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+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—
+3K142100AixplorerSupersonic Imagine201463—
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+3K132171AixplorerSupersonic Imagine201364—
+3K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+3K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+3K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+3K111142Echosoft (TM)Echometrix, LLC20120—
+3K121329AixplorerSupersonic Imagine2012405—
+3K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+3K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+3K102041AixplorerSupersonic Imagine2010527—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+3K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+3K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+3K091680Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.200925—
+3K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+3K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081873Emp-2100 Full Digital Ultrasound Diagnostic DeviceShenzhen Emperor Electronic Technology Co., Ltd.20083—
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+3K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+3K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc.20087239
+3K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+3K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.2006803
+3K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A.200560—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K212616Koios DSKoios Medical, Inc.20214—
+4K203555AmCAD-UTAmcad Biomed Corporation20212—
+4K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+4K201555EchoGo ProUltromics, Ltd.20206—
+4K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+4K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+4K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+4K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+4K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—