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
+8K162148Allura Xper R9Philips Medical Systems Nethrlands BV201683
+8K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.201610—
+8K161563Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.2016245
+8K1618392D Quantitative AnalysisPhilips Medical Systems Nederland B.V.20160—
+8K150306D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions20150—
+8K152577Ultrasound System Sonimage HS 1Konica Minolta, Inc.201532
+8K151904SyncVision SystemVolcano Corporation201521
+8K151485GenesisDornier Medtech America, Inc.20151—
+8K133434Genesis IIDornier Medtech America, Inc.20142—
+8K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+8K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+8K130729Extra Corporeal Shockwave LithotripterDornier Medtech Systems20130—
+9K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+9K262390BoneXpertVisiana20260—
+9K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+9K251417ReVISION 2Argus Cognitive, Inc.20260—
+9K260192DIANAROPCA ApS20260—
+9K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+9K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+9K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+9K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+9K252503Intelligent NRCanon, Inc.20260—
+9K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+9K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+9K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+9K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+9K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+9K250914MediAI-BACrescom Co., Ltd.20250—
+9K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+9K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+9K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K251322Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+9K250543Voluson™ Performance 16; Voluson™ Performance 18GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K242594DeepechoDeepecho20250—
+9K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+9K2434463DXRGE Medical Systems SCS20250—
+9K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+9K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+9K242359Strain AI (SAI001)Exo, Inc.20240—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+9K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A)…Siemens Medical Solutions USA, Inc.2024211
+9K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+9K242223SuperSonic HepaVuSupersonic Imagine20240—
+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—
+9K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+9K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+9K233955Clarius OB AIClarius Mobile Health Corp.20240—
+9K233543YSIO X.preeSiemens Medical Solutions20241—
+9K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+9K240406Sonio DetectSonio20244—
+9K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—
+9K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+9K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+9K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+9K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+9K232501AI Platform (AIP001)Exo, Inc.20231—
+9K231995AcuityUDRRadmedix, LLC20230—
+9K232344Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 ORGE Medical Systems SCS202317
+9K232336ES Series V2E-Scopics20232—
+9K223287VelacurSonic Incytes20233—
+9K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+9K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+9K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+9K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+9K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+9K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+9K220933QT Scanner 2000 Model AQt Imaging, Inc.20221—
+9K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+9K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+9K220432ARTIS icono (VE21) SystemSiemens Medical Solutions USA, Inc.202244
+9K220409ARTIS pheno (VE21) SystemSiemens Medical Solutions USA, Inc.202242
+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—
+9K221335D²RS and D²RS 9090Stephanix20220—
+9K212376Caas QardiaPie Medical Imaging BV20220—
+9K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+9K220871NautilusDornier Medtech America, Inc.20220—
+9K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+9K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+9K214039Logiq P10, Logiq P9, Logiq P8GE Medical Systems Ultrasound and Primary Care Diagnostics202203
+9K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+9K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+9K213275EchoGo Core (2.0)Ultromics Limited20211—
+9K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+9K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+9K210309Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.202121
+9K210054Cios SpinSiemens Medical Systems USA, Inc.202131
+9K210055Cios AlphaSiemens Medical Solutions USA, Inc.202111
+9K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—