510(k) Report

Devices descending from K021497

898 later devices reach Cypress Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+1K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+1K022896CSV12 Software ViewerAcuson Corp.2002104—
+2K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+2K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+2K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+2K092204PMD ViewerSpencer Technologies20090—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+2K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+2K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+3K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+3K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+3K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+3K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+3K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+3K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+3K140254EZONO 4000Ezono AG201413—
+3K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+3K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+3K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+3K070515A-View Basic and PlusCordatec N.V.20071—
+3K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+4K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+4K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K170338A-ViewStroke2prevent B.V.20170—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K160420SpeqTSignostics Limited20161—
+4K152250SpeqRTSignostics Limited20150—
+4K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+4K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+4K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+4K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+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—
+5K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+5K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+5K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K181574UscanEchoNous, Inc.20180—
+5K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+5K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+5K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+5K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+5K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+5K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+5K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+5K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+5K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—