510(k) Report

Devices descending from K940942

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20046774
+1K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc.20002071
+1K992155Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model…Medison America, Inc.1999208—
+2K092058Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.2009272
+2K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc.20082472
+2K071134Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc.20072592
+2K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc.20056763
+2K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd.2005131—
+2K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc.2003132—
+2K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc.20031845
+2K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc.2001204—
+2K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc.200132—
+3K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+3K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+3K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+3K143046Xario 100, V3.0Toshibamedical Systems Corporation201411
+3K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+3K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K113832Soniceye Ultrasound TransducerBlacktoe Medical Iii, Inc.20120—
+3K113156Sonosite Edge Ultrasound SystemSonosite,Inc.20112161
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+3K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+3K102390Sonosite Nanomaxx Series Ultrasound SystemSonosite,Inc.20100—
+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
+3K093462Sonix Ultrasound ScannerUltrasonix Medical Corporation200979—
+3K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+3K082456Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600Verathon Incorporated200803
+3K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008582—
+3K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation2008584—
+3K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+3K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2006129—
+3K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+3K060087Accuvix V7 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+3K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+3K043588Mylab 15 / Mylab 20, Model 2700Pie Medical200530—
+3K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd.2004182—
+3K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC20040—
+4K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+4K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+4K182628Imagio Ultrasound Imaging SystemSeno Medical Instruments, Inc.20190—
+4K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+4K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+4K162155Xario 200 Diagnostic Ultrasound System V5.0Toshibamedical Systems Corporation201641
+4K162187Xario 100 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201601
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+4K133533Logiq EGE Healthcare2014149—
+4K133431VENUE 50GE Healthcare201360—
+4K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc.20137—
+4K122583Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2012108—
+4K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+4K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+4K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128—
+4K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+4K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+4K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+4K120703Zonare ZS3 Diagnostic Unltrasound SystemZonare Medical Systems, Inc.201224—
+4K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+4K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+4K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K112339Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011109—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K103397Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd.2011110—
+4K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K101455Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2010112—
+4K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+4K093714Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2009111—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+4K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2008124—
+4K070903MYLAB40Esaote Europe B.V.200727—
+4K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+4K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+4K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+5K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+5K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+5K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K172276Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation20173—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—