510(k) Report

Devices descending from K963705

403 later devices reach Color Enhancement Function for the Ssa-380A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991858Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C1999212—
+1K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C1999203—
+2K051334Terason Ultrasound System with Continuous Wave SopplerTeratech Corp.20055—
+2K013633Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C2001211—
+2K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc.1999196—
+3K082147Bodymetrix BX2000Intelametrix, Inc.20092—
+3K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+3K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2007135—
+3K032281Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2003209—
+3K022400Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C20022101
+3K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.2001592
+4K202514EchoS FamilyEcholight S.P.A20211—
+4K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+4K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+4K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+4K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+4K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715—
+4K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+4K042140Olympus BF Type UC160-OL8Olympus Corporation2004431
+4K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+4K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.200344—
+5K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+5K160420SpeqTSignostics Limited20161—
+5K152250SpeqRTSignostics Limited20150—
+5K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+5K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—
+5K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp.20126—
+5K121035Fujinon/Fujifilm Ultrasonic Endoscope EB-530USFujifilm Medical System U.S.A., Inc.20122—
+5K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+5K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+5K072826Aplio Artida Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2007182—
+5K072000Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C2007203—
+5K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation2007113
+5K053043Encompass Software PackageToshiba America Medical Systems, In.C20050—
+5K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation2005285
+5K050380Xario Diagnostic Ultrasound System, Model Ssa-660AToshiba America Medical Systems, In.C200502
+6K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation20250—
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+6K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+6K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.201921
+6K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+6K182825FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20190—
+6K181574UscanEchoNous, Inc.20180—
+6K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+6K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.201612
+6K151315Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20153—
+6K151895Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20150—
+6K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+6K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+6K142909Flexible 19G EBUS NeedleSpiration, Inc.20157—
+6K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+6K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K130058Endoscopic Ultrasound Center EU-Y0008Olympus Medical Systems Corp.20134—
+6K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+6K093195Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-OCook Ireland, Ltd.20108—
+6K091257Medi-Globe Sonotip II Ebus-Tbna Needle SystemMedi-Globe Corporation20093—
+6K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085—
+6K081065Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C2008118—
+6K080160Aplio Artida, Model SSH-880CV Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C2008181—
+6K072918Model Ssa-680A Xario XG Diagnostic Ultrasound System, Version 1.00Toshibamedical Systems Corporation200703
+7K260401Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)Olympus Medical Systems Corporation20260—
+7K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+7K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+7K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K180668Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025NOlympus Medical Systems Corp.20180—
+7K180995Vscan ExtendGE Medical Systems Ultrasound and Primary Care Diagnostics2018107
+7K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+7K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…Pentax of America, Inc.20180—
+7K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+7K171594AccuroRivanna Medical, LLC20173—
+7K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+7K163248Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation20172—
+7K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+7K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+7K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+7K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+7K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+7K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+7K152922ViziShot FLEXSpiration, Inc.20166—
+7K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+7K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+7K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+7K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+7K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+7K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+7K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+7K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+7K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+7K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+7K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+8K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+8K250145Biopsy Port AdapterEndosound, Inc.20250—
+8K243937Accuro 3SRivanna Medical, Inc.20252—