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
+1K110920UF-760AGFukuda Denshi Co., Ltd.20111—
+1K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+1K061682GE Voluson E8 Ultrasound SystemGeneral Electric Co.20065543
+1K053435GE Voluson IGeneral Electric Co.2005407—
+1K041688GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co.20047081
+1K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+1K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+1K032620GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co.2003864—
+1K023720Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.20028961
+1K022303Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound TransducerPhilips Ultrasound, Inc.20021,155—
+2K131973Unexef-38G Ultrasound SystemToyota Tsusho Corporation20140—
+2K132690UP600 Diagnostic Doppler Ultrasound SystemQisda Corporation20143—
+2K131937Voluson I/EGE Healthcare201335—
+2K121983Diagnostic Doppler Ultrasound System Curved Linear Array 2-5 MHZ Transducer Linear Array…Benq Medical Technology Corpation20120—
+2K120741Voluson S6, Voluson S8GE Healthcare2012295—
+2K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+2K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+2K103649Voluson S6, Voluson S8GE Healthcare2011296—
+2K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+2K101236Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMGE Healthcare2011445—
+2K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+2K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+2K1011664D-View 9.1 (4D View PC Software) Model: H48651SZGE Healthcare20100—
+2K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+2K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+2K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080930Modification to Automated Breast Ultrasound System, Model AbusU-System, Inc.200831
+2K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+2K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+2K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+2K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.200564—
+2K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+2K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+2K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+2K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+2K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+2K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc.20048824
+3K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+3K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+3K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+3K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+3K142100AixplorerSupersonic Imagine201463—
+3K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K141870Breast Volume NavigatorMetritrack, LLC20142—
+3K141639Voluson S6, Voluson S8GE Healthcare2014151—
+3K140364Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex…Chison Medical Imaging Co., Ltd.20140—
+3K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201483—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+3K133533Logiq EGE Healthcare2014149—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+3K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+3K132171AixplorerSupersonic Imagine201364—
+3K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+3K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+3K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+3K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013270—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+3K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+3K122387Voluson P6, Voluson P8GE Healthcare2012201—
+3K121329AixplorerSupersonic Imagine2012405—
+3K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+3K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+3K120801Chison Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20121—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+3K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+3K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+3K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+3K120525Qlab Quantification SoftwarePhilips Healthcare Group201292—
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113359Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex…Chison Medical Imaging Co., Ltd.20120—
+3K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K112213Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare20114041
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+3K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+3K110688MylabgoldEsaote2011251
+3K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—