510(k) Report

Devices descending from K964309

1,024 later devices reach Sonos 2000, Sonos 2500 (M2406 a) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+8K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+8K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+8K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+8K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+8K152922ViziShot FLEXSpiration, Inc.20166—
+8K142100AixplorerSupersonic Imagine201463—
+8K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+8K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+8K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+8K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+8K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+8K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+8K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+8K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+8K132171AixplorerSupersonic Imagine201364—
+8K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+8K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+8K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+8K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+8K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+8K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+8K121329AixplorerSupersonic Imagine2012405—
+8K121138Acuson S3000 Diagnostic Ultrasound SystemSiemens Medical Solution2012198—
+8K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+8K102041AixplorerSupersonic Imagine2010527—
+8K093466HI Vision Preirus Doagnostic Ultrasound Scanner Model HI Vision PreirusHitachi Medical Systems America, Inc.2010961
+8K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc.20105882
+8K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+8K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+8K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+8K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+8K081148Siemens Acuson 2000 Ultrasound System with Abvs TransducerSiemens Medical Solutions USA, Inc., Ultrasound DI20083253
+8K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+8K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+8K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+8K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+8K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K260748ES-SeriesE-Scopics20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K254021Accuro XVRivanna Medical, Inc.20260—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250145Biopsy Port AdapterEndosound, Inc.20250—
+9K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+9K250120GECHONarnar, LLC20250—
+9K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+9K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+9K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+9K231267ClearTipFinemedix Co., Ltd.20231—
+9K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+9K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+9K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+9K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+9K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+9K212100KosmosEchoNous, Inc.202101
+9K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+9K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+9K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+9K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+9K190669EndoticsEra Endoscopy S.R.L.20200—
+9K191647QLAB Advanced Quantification SoftwarePhilips Health Care201941—
+9K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+9K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd.20190—
+9K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+9K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+9K190913QLAB Advanced Quantification Software 13Philips Health Care20191—
+9K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+9K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+9K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+9K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+9K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+9K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+9K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+9K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+9K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+9K161999AixplorerSupersonic Imagine201620—
+9K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+9K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—