510(k) Report

Devices descending from K043455

182 later devices reach SA8000 SE Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+1K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+1K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+1K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+1K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+2K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+2K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+2K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+2K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+2K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+2K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+2K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+2K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+2K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+2K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+2K070903MYLAB40Esaote Europe B.V.200727—
+2K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+3K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+3K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+3K142077MylabgammaEsaote, S.p.A.201453
+3K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+3K140677MylabssognoEsaote, S.p.A.20140—
+3K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+3K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+3K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+3K121384MylabsognoEsaote, S.p.A.201211
+3K113184Logicscan 64 Logicscan 128Telemed20124—
+3K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011102—
+3K110688MylabgoldEsaote2011251
+3K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+3K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+3K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+3K083882MylabfiveEsaote Europe B.V.200926—
+4K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+4K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+4K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+4K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+4K173486NTU-USB Ultrasound USB BoxNational Taiwan University20180—
+4K163121SmartUs EXT-1M/3MTelemed20172—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+4K161999AixplorerSupersonic Imagine201620—
+4K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+4K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+4K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+4K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+4K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+4K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+5K211248ArtUsTelemed20220—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+6K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K2120216430 MyLabX75, 6430 MyLab XPro75Esaote, S.p.A.20210—
+7K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+7K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+7K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+7K200655FibroScan® 630Echosens20200—
+7K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+7K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+7K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+7K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+7K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+7K1619555D ViewerSamsung Medison Co., Ltd.20163—
+7K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+7K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+8K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+8K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+8K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+8K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+8K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+8K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—