510(k) Report

Devices descending from K933743

747 later devices reach SSA-380A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+7K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2011108—
+7K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+7K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+7K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+7K103677M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011123—
+7K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+7K103722The Sonoace R5 Diagnostic Ultrasound SystemMedison Co., Ltd.2011103—
+7K101605Mylabone Ultrasound SystemEsaote Europe B.V.201025—
+7K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd.2010110—
+7K100931Mylabtwice, Model 6200Esaote, S.p.A.201046—
+7K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+7K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+7K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+7K081386Model 6150 (MYLAB70) and Model 6100 (MYLAB90)Esaote, S.p.A.2008532
+7K082596Ultraextend Usws-900AToshiba America Medical Systems, In.C200882—
+7K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+7K081794Model 7340 Ultrasound SystemEsaote, S.p.A.200857—
+7K071996MYLAB30, Model 7300Esaote, S.p.A.20070—
+8K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+8K250145Biopsy Port AdapterEndosound, Inc.20250—
+8K243937Accuro 3SRivanna Medical, Inc.20252—
+8K231267ClearTipFinemedix Co., Ltd.20231—
+8K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+8K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+8K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+8K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+8K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+8K211248ArtUsTelemed20220—
+8K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+8K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+8K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+8K200708Vivid iqGe Medical Systems Ultrasound And20203—
+8K200411Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+8K193518KosmosEchoNous, Inc.20201—
+8K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+8K190669EndoticsEra Endoscopy S.R.L.20200—
+8K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+8K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+8K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K173486NTU-USB Ultrasound USB BoxNational Taiwan University20180—
+8K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+8K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+8K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+8K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+8K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+8K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+8K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+8K163121SmartUs EXT-1M/3MTelemed20172—
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+8K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+8K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+8K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+8K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K161168MyLabSix Ultrasound SystemEsaote Europe B.V.20161—
+8K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+8K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound SystemEsaote, S.p.A.201645
+8K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201612—
+8K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+8K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+8K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+8K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+8K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+8K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+8K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+8K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+8K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+8K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+8K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+8K142077MylabgammaEsaote, S.p.A.201453
+8K140677MylabssognoEsaote, S.p.A.20140—
+8K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+8K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+8K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+8K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+8K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+8K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+8K121577Aplio Artida Diagnostic Ultrasound SystemToshiba Medical Systems Corporation, Japan201229—
+8K121384MylabsognoEsaote, S.p.A.201211
+8K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+8K110688MylabgoldEsaote2011251
+8K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+8K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+8K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+9K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—