510(k) Report

Devices descending from K961459

1,077 later devices reach Level 10 Hdi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070195Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42BBroadsound Corporation20070—
+1K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation200416—
+1K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+1K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+1K030455Boris Platform Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.200353531
+1K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc.2002124—
+1K014116Hand-Carried Ultrasound SystemSonosite,Inc.2001433—
+1K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+1K994373Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer…Atl Ultrasound, Inc.200027—
+1K990248Dicom Image Manager, Model 3-D Visualization OptionDicomit Imaging Systems Corp.1999213—
+1K990256CRX World ShuntPhoenix Biomedical Corp.19990—
+1K974269SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc.1998215—
+1K981397Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…Toshiba America Medical Systems, In.C1998403—
+1K980687Sonos 5500 Ultrasound Imaging SystemHewlett-Packard Co.19981—
+1K981404Fukuda Denshi Ultrasound Scanners Models UF-3500 and UF-4500Fukuda Denshi USA, Inc.19980—
+1K981510Sonoace 6000/ Ultramark 400Medison America, Inc.1998212—
+2K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+2K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.201321136
+2K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+2K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20125322
+2K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc.2010339—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K091970Aixplorer Ultrasound SystemSupersonic Imagine2009528—
+2K091804CX50 Version 2.0 Diagnostic Ultrasound System and TransducersPhilips Ultrasound, Inc.2009577
+2K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+2K090059Imago C21 Diagnostic Ultrasound SystemSaset (Chengdu), Inc.20091—
+2K083877Flying Diagnostic Ultrasound SystemNeusoft Medical Systems Co., Ltd.20090—
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K080049Vascuview Ultrasound SystemEscalon Medical Corp.20080—
+2K070515A-View Basic and PlusCordatec N.V.20071—
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K070982CTS-7700 Digital Ultrasound Imaging SystemShantou Institute of Ultrasonic Instuments20071—
+2K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+2K043452Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc.200411—
+2K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+2K033604Tringa Ultrasound Imaging System, Model 50LPie Medical20030—
+2K033367Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Sonosite,Inc.200313—
+2K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp.200324—
+2K023957Sonosite Hand-Carried Ultrasound System (C2 Series)Sonosite,Inc.20020—
+2K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc.2001204—
+2K012867Sonoace 9900 Diagnostic Ultrasound SystemMedison America, Inc.2001132—
+2K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc.20002071
+2K992886Powerview Ultrasound Workstation, Uidm-400AToshiba America Medical Systems, In.C1999212—
+2K993517Combison 530D/Voluson 530D, Tissue Harmonic Imaging (Thi) OptionMedison America, Inc.19990—
+2K992470Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc.1999208—
+2K984639The S-Vna 5-8(B) Diagnostic Ultrasound TransducerMedison America, Inc.19990—
+2K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C1999212—
+2K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+2K990970Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Medison America, Inc.1999209—
+2K990400Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemHewlett-Packard Co.19990—
+3K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+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—
+3K170338A-ViewStroke2prevent B.V.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
+3K160420SpeqTSignostics Limited20161—
+3K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+3K152250SpeqRTSignostics Limited20150—
+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—
+3K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+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—
+3K140808Q-StationPhilips Ultrasound, Inc.201402
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+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—
+3K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20115610
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+3K102041AixplorerSupersonic Imagine2010527—
+3K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+3K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+3K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.2010101
+3K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+3K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—