510(k) Report

Devices descending from K050034

921 later devices reach Sonoline Antares Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+5K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+5K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+5K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+5K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation201439—
+5K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+5K142054Imacor Zura Evo Imaging SystemImacor, Inc.201401
+5K142077MylabgammaEsaote, S.p.A.201453
+5K141641Zonare ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201421—
+5K141486Mylabsix Ultrasound SystemEsaote Europe B.V.20148—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K140666MR ElastographyPhilips Medical Systems Nederland B.V.20142—
+5K140808Q-StationPhilips Ultrasound, Inc.201402
+5K1339056200 / 6250 Ultrasound SystemEsaote, S.p.A.201434—
+5K134016Arietta 70/Arietta S70/Arietta V70 Diagnostic Ultrasound ScannerHitachi Aloka Medical,Ltd. (Hitachi Aloka Medical2014252
+5K140030DC-N3/DC-N3S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20145—
+5K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+5K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+5K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+5K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322—
+5K132544Tomtec-Arena 1.0, Tomtec-Arena 3D Echo, Cardio-ArenaTomtec Imaging Systems GmbH201378—
+5K132779DC-N2/DC-N2S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201372—
+5K132527Digital Color Doppler Ultasound SystemSonoscape Company Limited201328—
+5K131690M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201392—
+5K130833DP-20 Digital Ultrasonic Diagnostic Imaging System; DP-30 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20130—
+5K130308Noblus Ultrasound Diagnostic SystemHitachi Aloka Medical, Ltd.201359—
+5K123806FibroscanEchosens201355—
+5K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20123231
+5K122114Logiq S7 Expert, Logiq S7 ProGE Healthcare20122201
+5K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+5K121646Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro20120—
+5K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K113632DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20120—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K112451S8 Diagnostic Ultrasound SystemSonoscape Company Limited20110—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH201180—
+5K110510S20 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20112—
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+5K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+5K103629Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C20116—
+5K1037824D MV-Assessment 2.0Tomtec Imaging Systems GmbH201179—
+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—
+5K102991M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010128—
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+6K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+6K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K243502Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)Olympus Medical Systems Corporation20250—
+6K243132Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…Shantou Institute of Ultrasonic Instruments Co., Ltd.20240—
+6K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K232518EndoSound Vision System; EVSEndosound, Inc.20230—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+6K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K220956Libby Echo:PrioDyad Medical, Inc.20221—
+6K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+6K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+6K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A20220—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K211726Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20214—
+6K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K210791Us2.v1Eko.Ai Pte Ltd. D/B/A Us2.Ai20213—
+6K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+6K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+6K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+6K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health202031
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200232LVivo Software ApplicationDia Imaging Analysis, Ltd.202019—
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+6K193518KosmosEchoNous, Inc.20201—
+6K192372ASCEND Image ViewerAscend Hit20200—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+6K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+6K192152DC-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—
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K1910727410 Ultrasound System (MyLabSigma)Esaote, S.p.A.20190—
+6K1909896400 Ultrasound System (MyLabX6, MyLabX7)Esaote, S.p.A.20190—
+6K183377DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K1904477400 Ultrasound SystemsNavigant Consulting - on Behalf of Esaote S.P.A.20190—
+6K190039EchoSure Diagnostic Ultrasound SystemSonavex, Inc.20191—
+6K190206DC-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—