510(k) Report

Devices descending from K935595

1,088 later devices reach Acuson Model 3001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.20021,069—
+1K973767Harmonic Imaging with ContrastAcuson Corp.19971,087—
+2K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+2K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100—
+2K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+2K061827Sonix Ultrasound ScannerUltrasonix Medical Corporation2006586—
+2K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+2K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+2K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+2K042326Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation2004590—
+2K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+2K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+2K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003—
+2K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+2K020630Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation2002595—
+2K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co.19991891
+2K981528Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.19981—
+2K980687Sonos 5500 Ultrasound Imaging SystemHewlett-Packard Co.19981—
+3K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+3K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K113613Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments20125—
+3K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+3K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+3K103761Visualize: VascularThe Medipattern Corporation20110—
+3K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K092907Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer…Shantou Institute of Ultrasonic Instuments20101—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+3K090059Imago C21 Diagnostic Ultrasound SystemSaset (Chengdu), Inc.20091—
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K082135ShowcaseTrillium Technology, Inc.20080—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K080223Zura Tee SystemImacor, LLC20085831
+3K072541Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc.20070—
+3K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070903MYLAB40Esaote Europe B.V.200727—
+3K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+3K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+3K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+3K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+3K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+3K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+3K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+3K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+3K041581Compacs, Version 1.0Intelligent Images Srl20041—
+3K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+3K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+3K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+3K992046Sonoline 7XX Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.19990—
+3K990400Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemHewlett-Packard Co.19990—
+4K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+4K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+4K182165Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd.20180—
+4K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+4K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+4K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+4K140254EZONO 4000Ezono AG201413—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+4K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+4K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+4K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+4K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521