510(k) Report

Devices descending from K935009

1,062 later devices reach Pegasus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991872Lynx Ultrasound SystemEcton, Inc.1999899—
+1K982800Ecton Lynx Ultrasound SystemEcton, Inc.1998899—
+1K964309Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co.19971,024—
+1K954028HP Sonos Ultrasound Imaging SystemHewlett-Packard Co.19961922
+2K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc.2005167—
+2K021497Cypress Ultrasound SystemAcuson Corp.20028982
+2K990400Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemHewlett-Packard Co.19990—
+2K981397Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…Toshiba America Medical Systems, In.C1998403—
+2K980687Sonos 5500 Ultrasound Imaging SystemHewlett-Packard Co.19981—
+2K972348HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co.19971901
+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—
+3K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C1999212—
+3K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+3K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co.19991891
+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—
+4K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+4K052895Foursight Viewtool Image ViewerSiemens Medical Solutions USA, Inc.2005102—
+4K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc.20058061
+4K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+4K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+4K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+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—
+5K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+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—
+5K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+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—
+5K131830Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.20131—
+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
+5K123249Diagnostic Ultrasound SystemEdan Instruments, Inc.201321—
+5K121807V5MS TransducerSiemens Medical Solutions USA, Inc.201201
+5K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+5K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+5K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+5K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+5K091941DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009177—
+5K090912Digital Ultrasonic Diagnostic Imaging System, Model DP-6900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2009114—
+5K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+5K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008178—
+5K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008179—
+5K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008180—
+5K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008182—
+5K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+5K070515A-View Basic and PlusCordatec N.V.20071—
+5K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006802—
+5K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+5K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+5K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+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—
+6K202514EchoS FamilyEcholight S.P.A20211—
+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—
+6K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+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—
+6K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—