510(k) Report

Devices descending from K974269

215 later devices reach SA8800 Diagnostic Ultrasound System and Transducers, through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070195Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42BBroadsound Corporation20070—
+1K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc.2001204—
+1K012867Sonoace 9900 Diagnostic Ultrasound SystemMedison America, Inc.2001132—
+1K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc.20002071
+1K993517Combison 530D/Voluson 530D, Tissue Harmonic Imaging (Thi) OptionMedison America, Inc.19990—
+1K992470Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, Inc.1999208—
+1K984639The S-Vna 5-8(B) Diagnostic Ultrasound TransducerMedison America, Inc.19990—
+1K990970Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Medison America, Inc.1999209—
+2K063580Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2006129—
+2K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd.2006114—
+2K060087Accuvix V7 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+2K052911Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd.2005131—
+2K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd.2004182—
+2K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc.2003132—
+2K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc.20031845
+2K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc.200132—
+2K992761Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc.199933—
+3K101829The Sonoace R3 Diagnostic Ultrasound SystemMedison Co., Ltd.2010104—
+3K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+3K093613Vascuview Tap Ultrasound SystemEscalon Medical Corp.20090—
+3K093714Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd.2009111—
+3K092159Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2009123—
+3K081676Sonoace X6 Diagnostic Ultrasound SystemMedison Co., Ltd.2008105—
+3K080800Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd.2008124—
+3K070813Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2007125—
+3K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A.200662—
+3K053530Sonoace X4 Diagnostic Ultrasound SystemMedison Co., Ltd.20060—
+3K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical200529—
+3K043588Mylab 15 / Mylab 20, Model 2700Pie Medical200530—
+3K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC20040—
+4K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+4K122583Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2012108—
+4K113184Logicscan 64 Logicscan 128Telemed20124—
+4K113381Mysono U6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011102—
+4K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+4K112339Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011109—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K103397Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd.2011110—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+4K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+4K101455Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010111—
+4K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+4K093849Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd.2010112—
+4K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+4K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+4K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+4K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+4K070903MYLAB40Esaote Europe B.V.200727—
+4K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V.200628—
+5K211248ArtUsTelemed20220—
+5K173486NTU-USB Ultrasound USB BoxNational Taiwan University20180—
+5K163121SmartUs EXT-1M/3MTelemed20172—
+5K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+5K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+5K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+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—
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K133505Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201398—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132861Ugeo H60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+5K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013101—
+5K130803Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013106—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K110688MylabgoldEsaote2011251
+5K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+5K083882MylabfiveEsaote Europe B.V.200926—
+6K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+6K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K161999AixplorerSupersonic Imagine201620—
+6K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+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—
+6K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+6K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+7K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+7K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—