510(k) Report

Devices descending from K032620

864 later devices reach GE Voluson 730 Pro/Expert BT03 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+3K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+4K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+4K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+4K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+4K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+4K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+4K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+4K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+4K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+4K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+4K160182LOGIQ S7 ExpertGE Healthcare2016361
+4K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+4K152543M9/M9CV/M9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201535—
+4K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+4K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+4K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+4K150239FibroScanEchosens201525—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+4K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+4K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+4K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+4K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+4K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+4K143452Logiq P9, Logiq P7GE Healthcare2015131—
+4K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+4K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K143472TE7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201538—
+4K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+4K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+4K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+4K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141768Logiq V5/Logiq V3GE Healthcare201457—
+4K141675Voluson P6, Voluson P8GE Healthcare201414—
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+4K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+4K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+4K140808Q-StationPhilips Ultrasound, Inc.201402
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+4K133034Logiq F SeriesGE Healthcare2014155—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+4K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+4K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+4K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+4K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+4K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+4K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+4K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+4K123806FibroscanEchosens201355—
+4K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+4K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+4K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+4K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare2012402—
+4K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+4K111582Logiq S8GE Healthcare20113673
+4K110943Logiq E9GE Healthcare20114722
+4K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—