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
+6K162529DigiX FDXAllengers Medical Systems Limited20176—
+6K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+6K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162583Aloka Lisendo 880Hitachi, Ltd.201602
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K160357TrinityKoelis20161—
+6K160790Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+6K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+6K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+6K160420SpeqTSignostics Limited20161—
+6K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+6K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015154—
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201554—
+6K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+6K152250SpeqRTSignostics Limited20150—
+6K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+6K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+6K150949FibroScanEchosens201542—
+6K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+6K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+6K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+6K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+6K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+6K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+6K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+6K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V.20141545
+6K133259Ysio MaxSiemens Medical Solutions USA, Inc.2014237
+6K1321472D PerfusionPhilips Medical Systems Nederland B.V.201321
+6K131766Platinum DRF Imaging SystemApelem-Dms Group20132—
+6K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+6K131263XperguidePhilips Medical Systems Nederland B.V.20131—
+6K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+6K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+6K122644Artis Zee/Zeego with CSX-10 Detector SW VC21Siemens Medical Solutions USA, Inc.2013301
+6K1311184D VIEWGE Healthcare20131—
+6K124053Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20131—
+6K123529Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc.20133331
+6K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+6K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+6K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+6K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+6K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+6K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+6K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+6K121513Multix FusionSiemens Medical Solution2012324
+6K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+6K113403GE Discovery Igs Angiographic,Fluoroscopic X-Ray SystemGE Medical Systems SCS201264
+6K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+6K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+6K113034GE Innova Solid State Xray Imager Flurosopic X Ray SystemGE Healthcare20116—
+6K111912Mobilett MiraSiemens Medical Solutions USA, Inc.201135
+6K111292Luminos AgileSiemens Medical Solutions USA, Inc.201126
+6K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+6K1035061.5T Head Coil (HC150), 3T Head Coil (HC300)Imris, Inc.20110—
+6K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+6K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+6K101337A6 Portable Ultrasonic Diagnostic SystemSonoscape Company Limited20101—
+6K101491Uroskop OmniaSiemens Medical Solutions USA, Inc.20101112
+6K093688Canon, Model Urs-50RFVirtual Imaging, Inc.20105—
+6K092439Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc.200910—
+6K081073HDR Vision, Vision HDR, HD R/F, Uromat HD R/FPausch, LLC20081—
+6K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+6K080859DRF 4343Villa Sistemi Medicali S.P.A.20082—
+7K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+7K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+7K250660LUMINOS Q.namix T; LUMINOS Q.namix RSiemens Medical Solutions202502
+7K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+7K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+7K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+7K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+7K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K233692Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary Care Diagnostics20240—
+7K230985Planmeca VisoPlanmeca Oy20233—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K232988Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20230—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+7K231764Ultrasound System 1300Bk Medical Aps202301
+7K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+7K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—