510(k) Report

Devices descending from K991805

1,093 later devices reach Aspen Ultrasound with Freestyle Imaging Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+4K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+4K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2005979—
+4K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+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—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+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—
+5K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+5K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+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—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K161999AixplorerSupersonic Imagine201620—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+5K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+5K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+5K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+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—
+5K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+5K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+5K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+5K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+5K102017SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20101041
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+5K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+5K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+5K080760Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2008278—
+5K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+5K072676Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc.20072795
+5K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+5K072365Sequoia Plus Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20072333
+5K070515A-View Basic and PlusCordatec N.V.20071—
+5K071036Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2007427—
+5K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+5K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+5K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+5K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+5K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+5K060879Model EC9-4 TransducerSiemens Medical Solutions USA, Inc.20061—
+5K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+5K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+5K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.2005972—
+5K051500Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C2005195—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+6K222406Clarius AIClarius Mobile Health Corp.20233—
+6K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+6K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+6K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+6K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+6K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K191171EchoGo CoreUltromics, Ltd.20193—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+6K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+6K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+6K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+6K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+6K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221