510(k) Report

Devices descending from K935595

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+8K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+8K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K223917Vinno E20, Vinno E10,Vinno E10P,Vinno E10E, Vinno X1,Vinno X1E,Vinno X1P, Vinno X2,Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+8K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+8K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+8K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K201990DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200655FibroScan® 630Echosens20200—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+8K193518KosmosEchoNous, Inc.20201—
+8K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+8K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+8K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+8K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+8K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+8K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+8K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+8K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+8K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+8K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+8K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+8K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+8K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics201813—
+8K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+8K173780EchoMD Automated Ejection Fraction SoftwareBay Labs, Inc.201810—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+8K173810Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd.20180—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+8K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+8K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+8K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+8K172342Voluson E6, Voluson E8, Voluson E10GE Healthcare201718—
+8K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+8K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+8K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+8K170521Trinity/3D Prostate SuiteKoelis20170—
+8K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K170445Logiq S8GE Healthcare2017191
+8K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+8K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+8K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+8K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics201673—
+8K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+8K162269Voluson E6, Voluson E8, Voluson E10GE Healthcare201641—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+8K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+8K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K1619555D ViewerSamsung Medison Co., Ltd.20163—
+8K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+8K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+8K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+8K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+8K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+8K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+8K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+8K153085Q Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20152—
+8K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+8K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—