510(k) Report

Devices descending from K993398

987 later devices reach Echo View, Easy View, Omni View through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+5K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+5K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20170—
+5K170856CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd20171—
+5K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10Medisono, LLC20170—
+5K161999AixplorerSupersonic Imagine201620—
+5K163020Xperius Ultrasound SystemPhilips Health Care201611
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K161382LVivo Software ApplicationDiacardio, Ltd.20160—
+5K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K152928Multitom RaxSiemens Medical Solutions USA, Inc.201531
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+5K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K150999Acclarix Diagnostic Ultrasound SystemEdan Instruments, Inc.201512—
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K150249ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201520—
+5K150122Tomtec-Arena TTA2Tomtec Imaging Systems GmbH2015561
+5K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical20140—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+5K142008Mylabseven, MylabalphaEsaote, S.p.A.2014193
+5K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K140677MylabssognoEsaote, S.p.A.20140—
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+5K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+5K131164AcusonSiemens Medical Solutions USA, Inc.2013124—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132231Mylabseven, MylabalphaEsaote, S.p.A.201322—
+5K132059Diagnostic Ultrasound SystemAdvanced Instrumentations, Inc.20130—
+5K130881Acuson S2000 and S3000Siemens Medical Solutions USA, Inc.2013116—
+5K132274AixplorerSupersonic Imagine2013312—
+5K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+5K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+5K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C20130—
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+5K130739Acuson S2000 and S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.2013177—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K120282CardnavPaieon, Inc.20120—
+5K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201297—
+5K122574Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6Edan Instruments, Inc.20121—
+5K112255AixplorerSupersonic Imagine2012525—
+5K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+5K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+5K121384MylabsognoEsaote, S.p.A.201211
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011116—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K112022Dus-3000/Dus-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.20110—
+5K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K110688MylabgoldEsaote2011251
+5K110447EchoinsightUltrasound Medical Devices, Inc.20110—
+5K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+5K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH201180—
+5K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+5K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+5K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+5K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+5K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+5K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+5K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+5K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+5K100079Digital Ultrasound ScannerShenzhen Well.D Medical Electronics Co., Ltd.20100—
+5K092596Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation200913—
+5K091166IMRXImris, Inc.20091—
+5K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc.2009697
+5K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH2009861
+5K091009MY LABS25 Gold/MYLAB30 Gold Cardiovascular Model 7340, MY LAB70/MY LAB70XVISION/MYLAB60…Esaote, S.p.A.200951—
+5K083882MylabfiveEsaote Europe B.V.200926—
+5K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+5K081722YSIOSiemens Medical Solutions USA, Inc.20084311
+5K080614DR Vision Neo, DR Vision DouAlmana Medical Imaging20080—