510(k) Report

Devices descending from K891689

901 later devices reach Mipron/Umipron through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982800Ecton Lynx Ultrasound SystemEcton, Inc.1998899—
+1K952540Sonos Imaging System (2000/2500 & 1000/1500)Hewlett-Packard Co.19960—
+2K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+2K021497Cypress Ultrasound SystemAcuson Corp.20028982
+3K100598Penrith Elettra Ultrasound SystemPenrith Corporation201064—
+3K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.200884—
+3K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+3K060992Syngo US WorkplaceSiemens Medical Solutions2006971
+3K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2004827—
+3K022896CSV12 Software ViewerAcuson Corp.2002104—
+4K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+4K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+4K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+4K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+4K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+4K092204PMD ViewerSpencer Technologies20090—
+4K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+4K091286Syngo US WorkplaceSiemens Medical Solutions USA, Inc.200995—
+4K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+4K082135ShowcaseTrillium Technology, Inc.20080—
+4K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+4K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+5K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+5K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K200644ACUSON Freestyle Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20207—
+5K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.201727—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+5K160420SpeqTSignostics Limited20161—
+5K152250SpeqRTSignostics Limited20150—
+5K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+5K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+5K140254EZONO 4000Ezono AG201413—
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+5K130159Qlab Quantification Software Heart ModelPhilips Health Care201392—
+5K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+5K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+5K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+5K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+5K070515A-View Basic and PlusCordatec N.V.20071—
+5K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+6K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K181574UscanEchoNous, Inc.20180—
+6K180039ACUSON P600 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201825—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K170338A-ViewStroke2prevent B.V.20170—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+6K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+6K141554Esie Apps SuiteSiemens Medical Solutions USA, Inc.20142—
+6K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+6K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc.2013911
+6K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20078019
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+7K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+7K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+7K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+7K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+7K171594AccuroRivanna Medical, LLC20173—
+7K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—