510(k) Report

Devices descending from K935595

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+4K122289Image-Com 5.0Tomtec Imaging Systems GmbH201279—
+4K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+4K120514CardiopacsLumedx20120—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K110688MylabgoldEsaote2011251
+4K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+4K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+4K1105954D Sono-Scan 1.0Tomtec Imaging Systems GmbH201179—
+4K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+4K103144Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui20110—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+4K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+4K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+4K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+4K083882MylabfiveEsaote Europe B.V.200926—
+4K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH200889—
+4K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+4K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+4K082510Image-Arena Applications, Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D…Tomtec Imaging Systems GmbH20080—
+4K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+4K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+4K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+4K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+4K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+4K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+4K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+4K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+4K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+4K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+4K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+4K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+4K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+4K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20059211
+4K043078Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C20041961
+4K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004927—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+5K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+5K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+5K192372ASCEND Image ViewerAscend Hit20200—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+5K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+5K161999AixplorerSupersonic Imagine201620—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K160420SpeqTSignostics Limited20161—
+5K152250SpeqRTSignostics Limited20150—
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+5K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+5K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+5K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K120282CardnavPaieon, Inc.20120—
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+5K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+5K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—