510(k) Report

Devices descending from K023720

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121384MylabsognoEsaote, S.p.A.201211
+5K113663Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201275—
+5K110870Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic…Toshiba America Medical Systems, In.C201189—
+5K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+5K111582Logiq S8GE Healthcare20113673
+5K110943Logiq E9GE Healthcare20114722
+5K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+5K110688MylabgoldEsaote2011251
+5K103649Voluson S6, Voluson S8GE Healthcare2011296—
+5K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+5K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+5K101874GE Logiq P6/P6 ProGE Healthcare2010221—
+5K101878GE Logiq P5 Model H44662LDGE Healthcare20100—
+6K260748ES-SeriesE-Scopics20260—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K250955XC11 ICE System, USAYorlabs, Inc.20250—
+6K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+6K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC20250—
+6K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+6K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+6K232186LOGIQ eGe Medical Systems Ultrasound and Primary Care Diagnostic,20231—
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+6K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+6K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+6K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+6K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+6K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+6K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+6K200655FibroScan® 630Echosens20200—
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+6K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K200251Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+6K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+6K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+6K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+6K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+6K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+6K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+6K182636DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20182—
+6K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard20184—
+6K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+6K182213QT Ultrasound Breast Scanner - 1Qt Ultrasound, LLC20183—
+6K180737Ultrasound Scanner System bk2300Bk Medical Aps20182—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+6K173569Ultrasound System 1300Bk Medical Aps20181—
+6K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+6K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+6K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+6K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+6K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+6K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+6K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+6K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+6K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+6K172970M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic UltrasoundShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K171579M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20170—
+6K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+6K171164U-Lite EXPSonoscanner20172—
+6K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201735—
+6K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+6K163119NaviSuite SSI EditionMedcom GmbH20171—
+6K163690DC-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—
+6K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+6K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+6K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+6K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+6K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+6K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+6K162172EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20161—
+6K162221ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group2016481
+6K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201653—
+6K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+6K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+6K1619555D ViewerSamsung Medison Co., Ltd.20163—
+6K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201612—
+6K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+6K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+6K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics201647—
+6K160524FibroScan 530 CompactEchosens201641—