510(k) Report

Devices descending from K042540

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K240115Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+8K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+8K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+8K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+8K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+8K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+8K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K232336ES Series V2E-Scopics20232—
+8K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+8K223287VelacurSonic Incytes20233—
+8K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+8K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+8K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+8K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+8K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+8K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+8K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+8K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+8K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+8K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+8K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+8K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+8K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K201768Voluson E10GE Healthcare20204—
+8K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K200138Versana PremierGe Medical Systems Ultrasound And20202—
+8K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+8K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+8K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+8K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+8K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+8K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+8K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+8K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+8K172574SyncVision SystemVolcano Corporation201701
+8K170315Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.2017451
+8K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+9K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+9K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+9K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+9K260589ES-SeriesE-Scopics20260—
+9K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+9K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+9K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+9K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+9K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+9K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+9K243684BrightHeart View ClassifierBrightheart20251—
+9K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K240645Sonix HealthOntact Health Co., Ltd.20240—
+9K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+9K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+9K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+9K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+9K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+9K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+9K232459VelacurSonic Incytes20232—
+9K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+9K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220851VenueGE Medical Systems20223—
+9K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+9K211488Logiq E10GE Healthcare202111—
+9K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+9K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+9K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+9K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—