510(k) Report

Devices descending from K040227

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+8K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K161756SyncVision SystemVolcano Corporation201611
+8K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+9K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K251199Allia MoveoGE Medical Systems SCS202501
+9K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+9K2503303mensio WorkstationPie Medical Imaging BV202501
+9K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250738YSIO X.preeSiemens Medical Solutions20250—
+9K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+9K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+9K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemCarbon (Shenzhen) Medical Device Co., Ltd.20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+9K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+9K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+9K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+9K233697SonoMax Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20241—
+9K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+9K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+9K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+9K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+9K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+9K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+9K230209Sonix HealthOntact Health Co., Ltd.20233—
+9K232336ES Series V2E-Scopics20232—
+9K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223287VelacurSonic Incytes20233—
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+9K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+9K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+9K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+9K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+9K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+9K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+9K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+9K201768Voluson E10GE Healthcare20204—
+9K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200138Versana PremierGe Medical Systems Ultrasound And20202—
+9K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+9K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+9K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+9K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+9K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+9K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+9K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+9K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+9K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+9K172574SyncVision SystemVolcano Corporation201701
+9K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+10K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+10K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+10K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+10K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+10K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K260589ES-SeriesE-Scopics20260—
+10K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+10K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+10K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+10K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+10K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+10K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+10K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+10K243684BrightHeart View ClassifierBrightheart20251—