510(k) Report

Devices descending from K010950

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+1K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+1K042593Acuson Acunav 8F Ultrasound CatheterSiemens Medical Solutions USA, Inc.2004930—
+1K021497Cypress Ultrasound SystemAcuson Corp.20028982
+2K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+2K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+2K082135ShowcaseTrillium Technology, Inc.20080—
+2K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+2K070011Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging CatheterIrvine Biomedical,Inc.(Ibi)20070—
+2K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+2K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+2K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20059271
+2K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+2K022896CSV12 Software ViewerAcuson Corp.2002104—
+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—
+3K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+3K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+3K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+3K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+3K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+3K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+3K092204PMD ViewerSpencer Technologies20090—
+3K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+3K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+3K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2009277—
+3K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20059261
+3K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+3K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+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—
+4K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+4K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K160420SpeqTSignostics Limited20161—
+4K152250SpeqRTSignostics Limited20150—
+4K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+4K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+4K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+4K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+4K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+4K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+4K140254EZONO 4000Ezono AG201413—
+4K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+4K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+4K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+4K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+4K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+4K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+4K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+4K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+4K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+4K093531Acuson Model X300 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.200999—
+4K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+4K070515A-View Basic and PlusCordatec N.V.20071—
+4K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006189—
+4K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+4K061946Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20064281
+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—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+5K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+5K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+5K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K181574UscanEchoNous, Inc.20180—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+5K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K170338A-ViewStroke2prevent B.V.20170—
+5K170069AmCAD-UVAmcad Biomed Corporation20170—