510(k) Report

Devices descending from K003525

1,255 later devices reach Voluson 730 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+9K202422Arietta 65Hitachi Healthcare Americas20200—
+9K201768Voluson E10GE Healthcare20204—
+9K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+9K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+9K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+9K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+9K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+9K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+9K191233Arietta 750Hitachi Healthcare Americas201901
+9K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+9K190248Arietta 50Hitachi Healthcare Americas20191—
+9K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+9K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+9K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+9K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+9K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+9K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+9K161756SyncVision SystemVolcano Corporation201611
+9K133277XARIO 100Toshibamedical Systems Corporation20142—
+10K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+10K261668Venue GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLC20260—
+10K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+10K253452Accuro 3SRivanna Medical, Inc.20260—
+10K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+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—
+10K254021Accuro XVRivanna Medical, Inc.20260—
+10K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+10K252433Sonio Detect (v3)Sonio20260—
+10K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.20260—
+10K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+10K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—
+10K250959BioticsAIBioticsai, Inc.20250—
+10K251199Allia MoveoGE Medical Systems SCS202501
+10K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+10K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+10K2503303mensio WorkstationPie Medical Imaging BV202501
+10K252007BlineSlideDeep Breathe, Inc.20250—
+10K250738YSIO X.preeSiemens Medical Solutions20250—
+10K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+10K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited20240—
+10K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+10K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K241380Fetoly-HeartDiagnoly20241—
+10K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+10K234141AISAP Cardio V1.0Aisap20240—
+10K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+10K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+10K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+10K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+10K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+10K231685TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20232—
+10K230209Sonix HealthOntact Health Co., Ltd.20233—
+10K232459VelacurSonic Incytes20232—
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+10K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+10K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+10K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+10K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+10K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+10K220295Arietta 50Fujifilm Healthcare Corporation20220—
+10K211488Logiq E10GE Healthcare202111—
+10K211524LOGIQ E10s, LOGIQ FortisGE Healthcare20218—
+10K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+10K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+10K172574SyncVision SystemVolcano Corporation201701
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+11K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+11K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+11K251368FetolyDiagnoly20250—
+11K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20251—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+11K243684BrightHeart View ClassifierBrightheart20251—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+11K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20241—
+11K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—