510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K222928Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20233—
+10K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+10K222406Clarius AIClarius Mobile Health Corp.20233—
+10K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+10K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+10K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+10K220051TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+10K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+10K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+10K212100KosmosEchoNous, Inc.202101
+10K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+10K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+10K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+10K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+10K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+10K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+10K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+10K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+10K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+10K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+10K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+10K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+10K191171EchoGo CoreUltromics, Ltd.20193—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+10K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+10K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+10K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+10K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+10K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+10K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+10K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+10K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+10K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+10K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+10K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+10K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+10K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+10K1808835D ViewerSamsung Medison Co., Ltd.20180—
+10K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+10K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+10K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+10K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+10K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+10K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+10K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+10K1725133D EchoJointvue, LLC20171—
+10K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+10K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+10K170841BiopSee, Mobile USMedcom GmbH20170—
+10K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K171766Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201720—
+10K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+10K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+10K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+10K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+10K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+10K163505Arietta PrecisionHitachi, Ltd.20170—
+10K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K170069AmCAD-UVAmcad Biomed Corporation20170—
+10K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+10K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+10K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+10K162583Aloka Lisendo 880Hitachi, Ltd.201602
+10K163020Xperius Ultrasound SystemPhilips Health Care201611
+10K161960bk2300Bk Medical Aps20165—
+10K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+10K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+10K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+10K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+10K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+10K152195Logiq S8GE Healthcare201557—
+10K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+10K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+10K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+10K150949FibroScanEchosens201542—
+10K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+10K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+10K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+10K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+10K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+10K131527Logiq S8GE Healthcare2013219—
+10K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+10K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+10K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+10K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+10K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+10K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+10K120741Voluson S6, Voluson S8GE Healthcare2012295—
+10K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+11K251417ReVISION 2Argus Cognitive, Inc.20260—
+11K260192DIANAROPCA ApS20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+11K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+11K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+11K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+11K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+11K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+11K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—