510(k) Report

Devices descending from K940942

737 later devices reach Combison 530 Diagnostic Ultrasound Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K161960bk2300Bk Medical Aps20165—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+5K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+5K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+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—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+5K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+5K151028LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics201560—
+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—
+5K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+5K143452Logiq P9, Logiq P7GE Healthcare2015131—
+5K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+5K142077MylabgammaEsaote, S.p.A.201453
+5K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+5K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+5K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+5K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K132861Ugeo H60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+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—
+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—
+5K130803Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013106—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+5K123001Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc.2012742
+5K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+5K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+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—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+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—
+5K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+5K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+5K083882MylabfiveEsaote Europe B.V.200926—
+5K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+5K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+5K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+6K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+6K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K211248ArtUsTelemed20220—
+6K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+6K200655FibroScan® 630Echosens20200—
+6K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+6K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+6K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—