510(k) Report

Devices descending from K051139

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+7K162583Aloka Lisendo 880Hitachi, Ltd.201602
+7K163020Xperius Ultrasound SystemPhilips Health Care201611
+7K161960bk2300Bk Medical Aps20165—
+7K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+7K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+7K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+7K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K152195Logiq S8GE Healthcare201557—
+7K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+7K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+7K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+7K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+7K141720iuStar300 Medical Ultrasound Diagnostic SystemUnited Imaging Systems (Beijing) Co., Ltd.20150—
+7K150949FibroScanEchosens201542—
+7K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+7K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+7K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+7K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+7K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+7K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+7K131527Logiq S8GE Healthcare2013219—
+7K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+7K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+7K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+7K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+7K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+7K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+7K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+7K120741Voluson S6, Voluson S8GE Healthcare2012295—
+7K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+7K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+7K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+8K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+8K253452Accuro 3SRivanna Medical, Inc.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K254021Accuro XVRivanna Medical, Inc.20260—
+8K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+8K2503303mensio WorkstationPie Medical Imaging BV202501
+8K252007BlineSlideDeep Breathe, Inc.20250—
+8K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+8K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+8K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+8K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+8K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited20252—
+8K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+8K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+8K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+8K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+8K234141AISAP Cardio V1.0Aisap20240—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+8K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+8K230209Sonix HealthOntact Health Co., Ltd.20233—
+8K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+8K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+8K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+8K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+8K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+8K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…Supersonic Imagine20221—
+8K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K220993Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20220—
+8K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+8K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+8K212012Follicle ClarityCycle Clarity20221—
+8K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+8K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+8K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+8K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+8K202785Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20215—
+8K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens20219—
+8K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+8K202364Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20201—
+8K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K201693DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+8K2013523D Auto LAAPhilips Health Care20200—
+8K200780XBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20202—
+8K200655FibroScan® 630Echosens20200—
+8K200497Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+8K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—