510(k) Report

Devices descending from K961459

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161960bk2300Bk Medical Aps20165—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K162549Lumify Ultrasound SystemPhilips Health Care2016436
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+5K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+5K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+5K161787ACUSON NX2 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2016301
+5K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20165—
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+5K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+5K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.20167—
+5K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K152922ViziShot FLEXSpiration, Inc.20166—
+5K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+5K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+5K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+5K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+5K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201561
+5K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K150239FibroScanEchosens201525—
+5K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+5K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+5K150949FibroScanEchosens201542—
+5K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemC.R. Bard, Inc.20150—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K143601U-LiteSonoscanner Sarl20153—
+5K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+5K143452Logiq P9, Logiq P7GE Healthcare2015131—
+5K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142100AixplorerSupersonic Imagine201463—
+5K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2014581
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+5K142077MylabgammaEsaote, S.p.A.201453
+5K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+5K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+5K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K132654Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro201353—
+5K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+5K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+5K130754Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201354—
+5K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+5K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+5K122583Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2012108—
+5K113184Logicscan 64 Logicscan 128Telemed20124—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011102—
+5K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K112339Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011109—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+5K103397Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd.2011110—
+5K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+5K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+5K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+5K101455Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+5K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+5K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2010112—
+5K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+5K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+5K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+5K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+5K070903MYLAB40Esaote Europe B.V.200727—
+5K063130Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation20062051
+5K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+5K060279Cryocare CS Surgical SystemEndocare, Inc.200693
+5K041499Ssa-770A, Aplio Version 5.5Toshibamedical Systems Corporation200423
+6K260748ES-SeriesE-Scopics20260—
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K250145Biopsy Port AdapterEndosound, Inc.20250—
+6K243937Accuro 3SRivanna Medical, Inc.20252—