510(k) Report

Devices descending from K030455

535 later devices reach Boris Platform Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160420SpeqTSignostics Limited20161—
+4K153421HI Vision Ascendus, HV Ascendus, AscendusHitachi Aloka Medical America, Inc.20160—
+4K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+4K150239FibroScanEchosens201525—
+4K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201596—
+4K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation2015342
+4K150002iNSIGHT Color Doppler Ultrasound SystemSaset (Chengdu), Inc.20150—
+4K150949FibroScanEchosens201542—
+4K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.2015581
+4K143089WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201499—
+4K142100AixplorerSupersonic Imagine201463—
+4K142160Logiq E9 Diagnostic Ultrasound SystemGE Healthcare20142631
+4K133329Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2013102—
+4K132804Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro2013733
+5K260748ES-SeriesE-Scopics20260—
+5K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+5K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K242223SuperSonic HepaVuSupersonic Imagine20240—
+5K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+5K233734Interson USB Ultrasound SystemInterson Corporation20230—
+5K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+5K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+5K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+5K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+5K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+5K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+5K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+5K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+5K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+5K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+5K200136Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co., Ltd.20202—
+5K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+5K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+5K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+5K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+5K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+5K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+5K191922ACUSON P200 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201923—
+5K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+5K182932RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201924—
+5K182595HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201826—
+5K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+5K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+5K181574UscanEchoNous, Inc.20180—
+5K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201814—
+5K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+5K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+5K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+5K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+5K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+5K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+5K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi, Ltd.20160—
+5K162065Ultrasound System SONIMAGE HS1Konica Minolta, Inc.201622
+5K160559NOBLUS™ Ultrasound Diagnostic SystemHitachi Medical Corporation201601
+5K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201659—
+5K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc.201601
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+5K160524FibroScan 530 CompactEchosens201641—
+5K153529WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016891
+5K153408HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201565—
+5K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201590—
+5K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201565—
+5K152195Logiq S8GE Healthcare201557—
+5K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics20151001
+5K1518083D/5D ViewerSamsung Medison Co., Ltd.20154—
+5K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201597—
+5K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS2015736
+5K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201498—
+5K141846Acuson X700 Ultrasound System, Acuson X600 Ultrasound SystemSiemens Medical Solutions USA, Inc.201441—
+5K141620RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2014101—
+5K140959Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc.201460—
+6K250026Shear Wave Quantificational Ultrasound Diagnostic System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+6K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.20250—
+6K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+6K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+6K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+6K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K230511K3900 Ultrasound Imaging SystemMaui Imaging20230—
+6K230768M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20231—
+6K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+6K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.20221—
+6K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+6K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+6K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+6K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+6K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—