510(k) Report

Devices descending from K022303

1,155 later devices reach Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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
+9K223287VelacurSonic Incytes20233—
+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—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+9K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+9K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+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—
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison 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—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201768Voluson E10GE Healthcare20204—
+9K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200138Versana PremierGe Medical Systems Ultrasound And20202—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+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—
+9K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+9K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K173739Aloka Arietta 850Hitachi Healthcare Americas Corporation201872
+9K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+9K172574SyncVision SystemVolcano Corporation201701
+9K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+9K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group2017481
+9K160357TrinityKoelis20161—
+9K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+9K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+9K151060Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201541
+9K150085GE EchoPACGe Vingmed Ultrasound AS20157—
+9K143452Logiq P9, Logiq P7GE Healthcare2015131—
+9K141639Voluson S6, Voluson S8GE Healthcare2014151—
+9K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485—
+9K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+9K133533Logiq EGE Healthcare2014149—
+9K133034Logiq F SeriesGE Healthcare2014155—
+9K133431VENUE 50GE Healthcare201360—
+9K131937Voluson I/EGE Healthcare201335—
+9K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+9K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+9K1311184D VIEWGE Healthcare20131—
+9K122387Voluson P6, Voluson P8GE Healthcare2012201—
+9K121937E-Cube InnoAlpinion Medical Systems Co., Ltd.201215—
+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—
+10K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+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—
+10K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+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—
+10K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+10K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K240645Sonix HealthOntact Health Co., Ltd.20240—
+10K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+10K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+10K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301