510(k) Report

Devices descending from K013627

204 later devices reach Sonoace SA-8000 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2006129—
+1K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+1K060087Accuvix V7 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+1K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd.2004182—
+1K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc.2003132—
+1K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc.20031845
+2K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+2K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+2K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+2K093714Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2009111—
+2K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+2K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2008124—
+2K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+2K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+2K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+2K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+2K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd.2005131—
+2K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC20040—
+3K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+3K113184Logicscan 64 Logicscan 128Telemed20124—
+3K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011102—
+3K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+3K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+3K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+3K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+3K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+3K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+3K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2010112—
+3K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+3K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+3K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+3K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+3K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+3K070903MYLAB40Esaote Europe B.V.200727—
+3K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+4K211248ArtUsTelemed20220—
+4K173486NTU-USB Ultrasound USB BoxNational Taiwan University20180—
+4K163121SmartUs EXT-1M/3MTelemed20172—
+4K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+4K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+4K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+4K142077MylabgammaEsaote, S.p.A.201453
+4K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+4K140677MylabssognoEsaote, S.p.A.20140—
+4K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+4K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+4K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+4K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+4K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+4K122583Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2012108—
+4K121384MylabsognoEsaote, S.p.A.201211
+4K112339Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011109—
+4K110688MylabgoldEsaote2011251
+4K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+4K103397Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd.2011110—
+4K101455Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K083882MylabfiveEsaote Europe B.V.200926—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+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—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—
+5K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+5K161999AixplorerSupersonic Imagine201620—
+5K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132861Ugeo H60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K130803Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013106—
+5K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+5K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+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—
+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—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K170841BiopSee, Mobile USMedcom GmbH20170—
+6K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+6K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+6K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+6K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+6K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+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—
+7K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+7K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—