510(k) Report

Devices descending from K993624

275 later devices reach Site-Rite 3 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313—
+1K032135Site-Rite IV Ultrasound SystemDymax Corp2003140—
+1K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp.200324—
+1K021984Punctsure Ultrasound Vascular Imaging System; Puncturesure Vascular Imaging Procedure KitInceptio Medical Technologies, LC20020—
+1K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc.2002124—
+2K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+2K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+2K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+2K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+2K080049Vascuview Ultrasound SystemEscalon Medical Corp.20080—
+2K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+2K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+2K061153Gynesonics EC6 TransducerGynesonics, Inc.20067—
+2K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc.2005139—
+2K033604Tringa Ultrasound Imaging System, Model 50LPie Medical20030—
+2K032333Cryocare CS Surgical SystemEndocare, Inc.200313—
+3K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+3K160420SpeqTSignostics Limited20161—
+3K152250SpeqRTSignostics Limited20150—
+3K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+3K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+3K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+3K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+3K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+3K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081—
+3K070515A-View Basic and PlusCordatec N.V.20071—
+3K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc.2007136—
+3K050347Modification to Cryocare CS Surgical SystemEndocare, Inc.200512—
+4K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+4K181574UscanEchoNous, Inc.20180—
+4K170338A-ViewStroke2prevent B.V.20170—
+4K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+4K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+4K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201464—
+4K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+4K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+4K093713Ultrasound General Purpose Guidance SystemCivco Medical Instruments201047
+4K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco20096117
+4K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+5K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.20260—
+5K262474ND Needle Guidance SystemAccurate Access, LLC20260—
+5K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K203657Vu-Path Ultrasound SystemCrystalline Medical20210—
+5K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K171594AccuroRivanna Medical, LLC20173—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis20170—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K143396omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions20150—
+5K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K133901Pari-Path Surgical Navigation SystemParitic, Inc.20140—
+5K131489Tractus Tissuemapper Image Recording System ApplicationTractus Corporation20132—
+5K111818Sonixgps Needle SensorUltrasonix Medical Corporation201215—
+5K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics20120—
+5K113680Soma Access Systems Exacttrack Procedure KitSoma Access Systems, LLC201101
+5K101333Cryocare CS Surgical SystemEndocare, Inc.201082
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20230—
+6K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+6K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+6K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+6K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.)20212—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K171309BR-FHUS Navigation 1.0Taihao Medical, Inc.20171—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+6K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K141110Cryocare CS Surgical SystemHealthtronics20157—
+6K140254EZONO 4000Ezono AG201413—
+7K253452Accuro 3SRivanna Medical, Inc.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K254021Accuro XVRivanna Medical, Inc.20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251673X9 Ultrasound SystemX9, Inc.20250—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—