510(k) Report

Devices descending from K052410

972 later devices reach Acuson Sequoia Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K112726Sonix Ultrasound ScannerUltrasonix Medical Corporation20110—
+4K110673HI Vision Ascendus Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.201185—
+4K111302Mylabseven, MylabalphaEsaote, S.p.A.201124—
+4K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+4K110414Qlab 8.1 Quantification SoftwarePhilips Ultrasound, Inc.20110—
+4K110688MylabgoldEsaote2011251
+4K110999Digital Ultrasonic Diagnostic Imaging SystemEdan Instruments, Inc.201122—
+4K102642Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased…Sonoscape Company Limited201129—
+4K110199DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2011117—
+4K1031526250 Ultrasound SytemsEsaote, S.p.A.201135—
+4K102997Sonixtablet Ultrasound ScannerUltrasonix Medical Corporation201077—
+4K102865DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20100—
+4K102901HI Vision Avius Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc.2010601
+4K101091Z.One Ultra Ultrasound SystemZonare Medical Systems, Inc.2010132—
+4K100989Zura Tee System with Claritee ProbeImacor, Inc.201011
+4K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010138—
+4K101041DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2010130—
+4K092922Ssi-8000/S8/S6 Digital Color Doppler Ultrasound System, 2P1 Phased Array Diagnostic…Sonoscape Company Limited201033—
+4K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20095691
+4K083421MR-Touch OptionGe Medical Systems, LLC20094—
+4K091295Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C2009222
+5K260748ES-SeriesE-Scopics20260—
+5K250955XC11 ICE System, USAYorlabs, Inc.20250—
+5K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K252105Ligence HeartLigence Uab20250—
+5K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—
+5K250670EchoConfidence (USA)Mycardium AI Limited20250—
+5K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+5K241554Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited20240—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K241430EchoMeasureIcardio.Ai20240—
+5K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+5K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+5K233676Us2.v2Eko.Ai Pte Ltd. D/B/A Us2.Ai20240—
+5K2301796440 MyLabX90Esaote, S.p.A.202341
+5K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+5K223322Argus Cognitive ReVISION SoftwareArgus Cognitive, Inc.20231—
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+5K222406Clarius AIClarius Mobile Health Corp.20233—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K213487ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc.20221—
+5K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+5K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+5K212100KosmosEchoNous, Inc.202101
+5K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+5K210053LVivo Software ApplicationDia Imaging Analysis, Ltd.202111—
+5K203128Evis Eus Endoscopic Ultrasound Center Olympus EU-ME2/Evis Eus Endoscopic Ultrasound…Olympus Medical Systems Corp.20201—
+5K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Siemens Medical Solutions USA, Inc.20206—
+5K202546LVivo SeamlessDia Imaging Analysis, Ltd.20202—
+5K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+5K201632Tomtec-ArenaTomtec Imaging Systems GmbH202010—
+5K201389Resoundant Acoustic Driver SystemResoundant, Inc.20201—
+5K200974QLAB Advanced Quantification SoftwarePhilips Health Care202012—
+5K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+5K201130ACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020144
+5K201062syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc.20200—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K191347Paragon XHD Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20200—
+5K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+5K191171EchoGo CoreUltromics, Ltd.20193—
+5K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+5K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20197—
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K183041Full Digital Colour Doppler Ultrasonic Diagnostic SystemWuhan Zoncare Bio-medical Electronics Co., Ltd.20190—
+5K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+5K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+5K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+5K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+5K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K180912TE7/TE5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201811—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K173810Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd.20180—
+5K180461Navi e/Navi s/Navi X Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20181—
+5K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+5K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-MFujifilm Medical Systems U.S.A, Inc.20181—
+5K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color…Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20173—
+5K173265UltraVision 2 Diagnostic Ultrasound SystemWinprobe Corporation20172—
+5K171594AccuroRivanna Medical, LLC20173—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+5K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201712
+5K171105AIXPLORER® & AIXPLORER® Ultimate Ultrasound SystemsSupersonic Imagine201719—
+5K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+5K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+5K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics2017353
+5K170374SonoBook Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20175—
+5K171314QLAB Advanced Quantification SoftwarePhilips Health Care201745—
+5K163119NaviSuite SSI EditionMedcom GmbH20171—