510(k) Report

Devices descending from K002003

823 later devices reach Hdi 5000 Ultrasound System with Extended Field of View Imaging through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070195Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42BBroadsound Corporation20070—
+1K061827Sonix Ultrasound ScannerUltrasonix Medical Corporation2006586—
+1K042326Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerUltrasonix Medical Corporation2004590—
+1K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+1K030455Boris Platform Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.200353531
+1K022858Supernova Diagnostic Ultrasound Scanning SystemNovasonics, Inc.2002134—
+1K020630Ultrasonix Ergosonix 500 Ultrasound ScannerUltrasonix Medical Corporation2002595—
+1K014182Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-Atp TransducersTetrad Corp.200201
+2K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+2K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20125322
+2K113613Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments20125—
+2K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+2K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+2K092907Digital Ultrasound Imaging System, Convex Array Transducer, Linear Array Transducer…Shantou Institute of Ultrasonic Instuments20101—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+2K091804CX50 Version 2.0 Diagnostic Ultrasound System and TransducersPhilips Ultrasound, Inc.2009577
+2K090059Imago C21 Diagnostic Ultrasound SystemSaset (Chengdu), Inc.20091—
+2K083877Flying Diagnostic Ultrasound SystemNeusoft Medical Systems Co., Ltd.20090—
+2K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+2K082326Zonare Ultra Ultrasound SystemZonare Medical Systems, Inc.2008133—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+2K080223Zura Tee SystemImacor, LLC20085831
+2K072541Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc.20070—
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+3K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+3K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+3K182165Color Doppler Ultrasound System; Model: mEye1 and mEye2Shenzhen Well.D Medical Electronics Co., Ltd.20180—
+3K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+3K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+3K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+3K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+3K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+3K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+3K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+3K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+3K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+3K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+3K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+3K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+3K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+3K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K112255AixplorerSupersonic Imagine2012525—
+3K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+3K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+3K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20115610
+3K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K103144Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array TransducerShantou Institute of Ultrasonic Instruments (Siui20110—
+3K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+3K102041AixplorerSupersonic Imagine2010527—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+3K083421MR-Touch OptionGe Medical Systems, LLC20094—
+3K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+4K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+4K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+4K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+4K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+4K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+4K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+4K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+4K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+4K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+4K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+4K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+4K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+4K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+4K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+4K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+4K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+4K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+4K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831