510(k) Report

Devices descending from K022567

1,069 later devices reach Sequoia Signature II Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201396—
+5K132062Esie Apps SuiteSiemens Medical Solutions USA, Inc.20133—
+5K130659Speqrt Ultrasound SystemSignostics Pty, Ltd.20134—
+5K123503DC-N3/DC-NS3 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201277—
+5K123622AcusonSiemens Medical Solutions USA, Inc.20129613
+5K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012109—
+5K121699Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201298—
+5K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012107—
+5K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2012103—
+5K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH201282—
+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—
+5K113179Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011100—
+5K113153DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201176—
+5K112596Acuson S2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI2011192—
+5K111435DP-50 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20112—
+5K111674AcusonSiemens Medical Solutions USA, Inc.20112233
+5K093706Proxiscan Model 101Hybridyne Imaging Technologies, Inc.20100—
+5K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2009176—
+5K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS2009130—
+5K083597Sonowand InviteSonowand AS20093—
+5K090505Speq Ultrasound SystemSignostics Pty, Ltd.2009107—
+5K090158Aplio Artida V2.0 SSH-880CVToshiba America Medical Systems, In.C2009985
+5K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc.2009330—
+5K0826844D Viewer Radiology, Model Uswp-100AToshiba America Medical Systems, In.C20080—
+5K082119Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C2008116—
+5K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007800—
+5K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI2007189—
+5K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007188—
+5K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc.20068383
+5K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005194—
+6K251417ReVISION 2Argus Cognitive, Inc.20260—
+6K260192DIANAROPCA ApS20260—
+6K260234MSK GoSmart Alfa Teknoloji San. Ve Tic. A.S.20260—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K252235PVAD IQ SoftwareUltrasight, Ltd.20250—
+6K250670EchoConfidence (USA)Mycardium AI Limited20250—
+6K250226Clarius Median Nerve AIClarius Mobile Health Corp.20250—
+6K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+6K242359Strain AI (SAI001)Exo, Inc.20240—
+6K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+6K232661Myocardial Strain Software ApplicationCircle Cardiovascular Imaging20231—
+6K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K232501AI Platform (AIP001)Exo, Inc.20231—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222970LVivo IQSDia Imaging Analysis, Ltd.20236—
+6K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+6K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+6K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic…Siemens Medical Solutions USA, Inc.20224—
+6K212376Caas QardiaPie Medical Imaging BV20220—
+6K213544Tomtec-ArenaTomtec Imaging Systems GmbH20226—
+6K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+6K213275EchoGo Core (2.0)Ultromics Limited20211—
+6K212466LVivo SeamlessDia Imaging Analysis, Ltd.20211—
+6K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+6K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+6K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2021153
+6K200603AAA ModelPhilips Ultrasound, Inc.20200—
+6K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+6K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+6K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20200—
+6K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+6K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+6K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+6K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+6K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+6K182603Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+6K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+6K173595Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20183—
+6K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc.201844—
+6K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+6K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201882
+6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+6K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+6K173369DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20172—
+6K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+6K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20161—
+6K160420SpeqTSignostics Limited20161—
+6K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201513—
+6K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemSiemens Medical Solutions, Inc., Ultrasound Division2015332
+6K152250SpeqRTSignostics Limited20150—
+6K150861QBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.20159—
+6K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd.201579—
+6K150628VentriPoint Medical SystemVentripoint, Inc.20151—
+6K150204DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.201571—
+6K142511U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.201513—
+6K150050ACUSON P500 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201528—
+6K143493SignosRT Bladder Ultrasound SystemSignostics, Ltd.20150—
+6K143254eSie Apps SuiteSiemens Medical Solutions USA, Inc.20141—
+6K142100AixplorerSupersonic Imagine201463—
+6K142628Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201450—
+6K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.20140—
+6K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+6K140693Vscan with Dual ProbeGe Medical Sysyems Ultrasound & Primary Care Diagn201429—