510(k) Report

Devices descending from K001400

982 later devices reach Elegra Millennium Enhanced Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+6K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+6K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+6K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+6K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+6K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+6K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+6K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+6K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+6K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+6K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+6K130695Z5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201374—
+6K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+6K123806FibroscanEchosens201355—
+6K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+6K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+6K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+6K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+6K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+6K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+6K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+6K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+6K111582Logiq S8GE Healthcare20113673
+6K110943Logiq E9GE Healthcare20114722
+6K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+6K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+6K103649Voluson S6, Voluson S8GE Healthcare2011296—
+6K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+6K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+6K103583DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010123—
+6K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+6K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+6K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+6K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+7K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+7K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+7K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+7K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+7K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+7K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+7K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+7K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+7K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+7K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+7K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+7K2301796440 MyLabX90Esaote, S.p.A.202341
+7K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+7K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+7K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+7K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+7K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+7K220956Libby Echo:PrioDyad Medical, Inc.20221—
+7K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+7K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+7K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+7K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+7K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+7K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+7K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+7K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+7K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+7K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+7K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+7K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+7K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+7K200655FibroScan® 630Echosens20200—
+7K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+7K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+7K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+7K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+7K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+7K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+7K193518KosmosEchoNous, Inc.20201—
+7K192372ASCEND Image ViewerAscend Hit20200—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+7K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+7K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+7K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+7K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+7K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+7K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+7K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+7K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+7K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+7K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+7K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+7K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+7K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+7K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20180—