510(k) Report

Devices descending from K021966

658 later devices reach Q Lab Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162574AmCAD-USAmcad Biomed Corporation20170—
+1K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+1K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+1K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+1K103761Visualize: VascularThe Medipattern Corporation20110—
+1K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+1K081843Ultrasound Data Analysis System, Model Das-RS1Aloka Co., Ltd.20080—
+1K062598Imt.Lab SoftwareEsaote Europe B.V.20060—
+1K050846B-Cad System, Version 1.0The Medipattern Corporation2005123—
+1K050376ProwinMedical Technologies International, Inc.200522—
+1K043360Imt.LabPie Medical200522—
+1K040686M'ath STDIntelligence IN Medical Technologies2004122—
+1K040399QontrastAmid20040—
+1K030223SonocalcSonometric Health, LLC20031461
+2K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+2K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+2K161959ClearView cCADClearview Diagnostics, Inc.2016131
+2K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+2K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+2K1619555D ViewerSamsung Medison Co., Ltd.20163—
+2K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+2K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+2K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+2K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+2K142100AixplorerSupersonic Imagine201463—
+2K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+2K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+2K132171AixplorerSupersonic Imagine201364—
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+2K130499IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20132122
+2K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+2K122022AtheroedgeAtheropoint, LLC20121—
+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—
+2K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+2K061961Art Lab SoftwarePie Medical200618—
+2K052023Cadimas Version 1.0Alan Penn & Associates., Inc.20050—
+3K203555AmCAD-UTAmcad Biomed Corporation20212—
+3K201369AVA (Augmented Vascular Analysis)See-Mode Technologies Pte, Ltd.20200—
+3K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+3K190442Koios DS for BreastKoios Medical, Inc.201912—
+3K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+3K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+3K1808835D ViewerSamsung Medison Co., Ltd.20180—
+3K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+3K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+3K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+3K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+3K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+3K1725133D EchoJointvue, LLC20171—
+3K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+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—
+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—
+3K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+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—
+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—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+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—
+3K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+4K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—