510(k) Report

Devices descending from K963315

405 later devices reach Vingmed Sound Color Flow Mapping System. System Five through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+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—
+8K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+8K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+8K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+8K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+8K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C201428—
+8K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+8K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+8K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+8K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+8K120282CardnavPaieon, Inc.20120—
+8K121076Ultraextend FX, Ultrasound Workstation PackageToshiba America Medical Systems, In.C20122—
+8K121422Aplio 500/400/300 Diagnostic Ultrasound SystemToshiba Medical Systems Coporation, Japan201285—
+8K100067Model Viamo Ssa-640A, Version 2.0 Ultrasound SystemToshiba America Medical Systems, In.C20101—
+8K093171Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C200911—
+8K092948Aplio MX Ssa-780A, Version 1.0Toshiba America Medical Systems, In.C200901
+8K092179Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Toshiba America Medical Systems, In.C200991
+9K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+9K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+9K250145Biopsy Port AdapterEndosound, Inc.20250—
+9K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+9K243937Accuro 3SRivanna Medical, Inc.20252—
+9K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+9K250328UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis ProgramCanon Medical Systems Corporation20250—
+9K231267ClearTipFinemedix Co., Ltd.20231—
+9K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+9K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+9K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+9K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+9K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+9K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+9K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+9K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+9K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+9K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+9K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+9K193518KosmosEchoNous, Inc.20201—
+9K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+9K192372ASCEND Image ViewerAscend Hit20200—
+9K190669EndoticsEra Endoscopy S.R.L.20200—
+9K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+9K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+9K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+9K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+9K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+9K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+9K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+9K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+9K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+9K163443Interson USB Ultrasound SystemInterson Corporation20173—
+9K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+9K161960bk2300Bk Medical Aps20165—
+9K162549Lumify Ultrasound SystemPhilips Health Care2016436
+9K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+9K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+9K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+9K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+9K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+9K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+9K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+9K111142Echosoft (TM)Echometrix, LLC20120—
+9K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+9K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+9K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+9K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+10K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+10K253452Accuro 3SRivanna Medical, Inc.20260—
+10K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+10K254021Accuro XVRivanna Medical, Inc.20260—
+10K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+10K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+10K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+10K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+10K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+10K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+10K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+10K233734Interson USB Ultrasound SystemInterson Corporation20230—
+10K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+10K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+10K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+10K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+10K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+10K222406Clarius AIClarius Mobile Health Corp.20233—
+10K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+10K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K212100KosmosEchoNous, Inc.202101
+10K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—