510(k) Report

Devices descending from K041319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+8K180974CBit Series Digital Color Doppler Ultrasound SystemCHISON Medical Technologies Co., Ltd.20183—
+8K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+8K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+8K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+8K1808835D ViewerSamsung Medison Co., Ltd.20180—
+8K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20180—
+8K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+8K180084Ultrasound System SONIMAGE MX1Konica Minolta, Inc.20181—
+8K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Group201802
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems2017203
+8K171708Aloka Arietta 850Hitachi Healthcare Americas Corporation201781
+8K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+8K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+8K1725133D EchoJointvue, LLC20171—
+8K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+8K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201721—
+8K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+8K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+8K170841BiopSee, Mobile USMedcom GmbH20170—
+8K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+8K163505Arietta PrecisionHitachi, Ltd.20170—
+8K163443Interson USB Ultrasound SystemInterson Corporation20173—
+8K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+8K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+8K162583Aloka Lisendo 880Hitachi, Ltd.201602
+8K163020Xperius Ultrasound SystemPhilips Health Care201611
+8K161960bk2300Bk Medical Aps20165—
+8K162290MyLabSix CrystaLineEsaote, S.p.A.20160—
+8K162549Lumify Ultrasound SystemPhilips Health Care2016436
+8K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc.201629—
+8K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+8K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+8K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc.201649—
+8K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+8K152195Logiq S8GE Healthcare201557—
+8K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+8K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+8K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+8K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+8K150949FibroScanEchosens201542—
+8K151175ZONARE ZS3 Diagnostic Ultrasound SystemZonare Medical Systems, Inc.201519—
+8K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+8K142197Ultrasound System Sonimage HS1, Linear Probe L18-4, Convex Probe C5-2Konica Minolta, Inc.201452
+8K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.2014843
+8K141261Logiq S7 Expert, Logiq S7 ProGE Healthcare2014144—
+8K131527Logiq S8GE Healthcare2013219—
+8K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS20131672
+8K123992Aplio 500/400/300 V3.0Toshibamedical Systems Corporation201382—
+8K122921C1-6-D Ultrasound TransducerGE Healthcare20120—
+8K122009Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd.20120—
+8K122327Voluson E6/E8/E8EXPERT/E10GE Healthcare2012365—
+8K122491Viamo Ssa-640A V4.0Toshibamedical Systems Corporation20120—
+8K122515C2-9-D Ultrasound TransducerGE Healthcare20120—
+8K120741Voluson S6, Voluson S8GE Healthcare2012295—
+8K113612Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd.20121—
+8K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20114691
+8K103148Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd.20112—
+9K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+9K253452Accuro 3SRivanna Medical, Inc.20260—
+9K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+9K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+9K252332FolliscanMim Fertility20260—
+9K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+9K254021Accuro XVRivanna Medical, Inc.20260—
+9K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20260—
+9K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.p.A.20250—
+9K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+9K2503303mensio WorkstationPie Medical Imaging BV202501
+9K252007BlineSlideDeep Breathe, Inc.20250—
+9K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+9K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+9K243479EchoGuide (Version 1)Sonavex, Inc.20250—
+9K243331LVivo SeamlessDia Imaging Analysis, Ltd.20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K241659Ultrasound Workspace (UWS 6.0)Philips Ultrasound, LLC20250—
+9K240553LVivo Software ApplicationDia Imaging Analysis, Ltd.20242—
+9K240953AI Platform 2.0 (AIP002)Exo Imaging20241—
+9K234141AISAP Cardio V1.0Aisap20240—
+9K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+9K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+9K240769LVivo IQSDia Imaging Analysis, Ltd.20240—
+9K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+9K233734Interson USB Ultrasound SystemInterson Corporation20230—
+9K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+9K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+9K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+9K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+9K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+9K230209Sonix HealthOntact Health Co., Ltd.20233—
+9K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+9K230160Vinno G86,Vinno G86E,Vinno G65,Vinno G65P,Vinno G65E,Vinno G65D,Vinno M86, Vinno…Vinno Technology (Suzhou) Co.,Ltd20230—
+9K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—