510(k) Report

Devices descending from K022567

1,069 later devices reach Sequoia Signature II Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+1K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+1K100363Ultra Dci Model 5000Ultrasound Medical Devices, Inc.20100—
+1K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+1K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K040546Image-Arena and Research-Arena ApplicationsTomtec Imaging Systems GmbH2004184—
+1K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+1K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20031,003—
+1K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20039551
+2K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+2K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+2K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+2K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+2K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+2K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+2K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+2K103761Visualize: VascularThe Medipattern Corporation20110—
+2K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+2K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+2K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+2K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+2K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+2K070903MYLAB40Esaote Europe B.V.200727—
+2K071232Image-Arena Applications and Research-Arena ApplicationsTomtec Imaging Systems GmbH200794—
+2K070077Ultrasound Scanner Profocus, Model 2202B-K Medical Aps20070—
+2K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+2K061396Qlab Quantification SoftwarePhilips Ultrasound, Inc.20060—
+2K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20049321
+2K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+2K042044Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20044291
+2K041581Compacs, Version 1.0Intelligent Images Srl20041—
+2K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+2K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004988—
+2K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2004950—
+3K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+3K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+3K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+3K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+3K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+3K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+3K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+3K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+3K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+3K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K142077MylabgammaEsaote, S.p.A.201453
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+3K140254EZONO 4000Ezono AG201413—
+3K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+3K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+3K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+3K120514CardiopacsLumedx20120—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K110688MylabgoldEsaote2011251
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+3K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+3K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+3K083882MylabfiveEsaote Europe B.V.200926—
+3K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+3K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+3K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+3K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+3K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+3K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+3K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+3K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+3K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+3K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+3K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+3K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+3K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+3K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+3K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+3K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+3K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+4K250955XC11 ICE System, USAYorlabs, Inc.20250—
+4K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+4K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+4K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—