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
+5K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+5K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K152195Logiq S8GE Healthcare201557—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+5K150239FibroScanEchosens201525—
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+5K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+5K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+5K143601U-LiteSonoscanner Sarl20153—
+5K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+5K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+5K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+5K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+5K131527Logiq S8GE Healthcare2013219—
+5K130779Lvivo EF SystemDiacardio, Ltd.201324—
+5K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+5K123806FibroscanEchosens201355—
+5K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K120282CardnavPaieon, Inc.20120—
+5K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+5K122574Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6Edan Instruments, Inc.20121—
+5K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+5K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+5K121223Qlab with FHN and VPQ Plug-inPhilips Ultrasound, Inc.201298—
+5K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K112022Dus-3000/Dus-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20110—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+5K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+5K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd.20100—
+5K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+5K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+5K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+5K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+5K091166IMRXImris, Inc.20091—
+5K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+5K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+5K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+5K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+5K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—
+5K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+5K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+5K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.20077820
+5K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+5K070526DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007117—
+5K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006193—
+6K260748ES-SeriesE-Scopics20260—
+6K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+6K250120GECHONarnar, LLC20250—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+6K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K242948Adora DRFi (04550010)Nrt X-Ray A/S20240—
+6K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K232895B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20240—
+6K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+6K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—