510(k) Report

Devices descending from K043016

927 later devices reach Sonoline Orchid Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213862HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20223—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20221—
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202261
+10K212012Follicle ClarityCycle Clarity20221—
+10K213102ES1 SystemE-Scopics20223—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K212900MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+10K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20213—
+10K211945V8 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202113—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+10K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+10K210154Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20210—
+10K212035FibroScan 230Echosens20215—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20212—
+10K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+10K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20210—
+10K203391TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20217—
+10K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K201768Voluson E10GE Healthcare20204—
+10K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K201693DC-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—
+10K2013523D Auto LAAPhilips Health Care20200—
+10K201597Liver Incytes, Model 1005Sonic Incytes20204—
+10K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+10K200643Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20201—
+10K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+10K200356Medo AriaMedo.Ai20203—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K192253SonicEye Dual-Array Ultrasound SystemSonivate Medical, Inc.20200—
+10K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+10K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+10K191493Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd.20191—
+10K192030RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20190—
+10K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+10K191541Vave Personal Ultrasound SystemVave Health, Inc.20191—
+10K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+10K183456Aloka Arietta 850Hitachi Healthcare Americas201923
+10K1827504D ViewGE Medical Systems Ultrasound and Primary Care Diagnostics20180—
+10K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+10K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare2018171
+10K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+10K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+10K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+10K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+10K181574UscanEchoNous, Inc.20180—
+10K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+10K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+10K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+10K173555Logiq E10GE Healthcare2017382
+10K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+10K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+10K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+10K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+10K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+10K172142FibroScan 430 Mini+Echosens20170—
+10K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+10K170521Trinity/3D Prostate SuiteKoelis20170—
+10K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+10K161588Vscan ExtendGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016258
+10K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+10K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+10K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+10K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+10K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+10K143601U-LiteSonoscanner Sarl20153—
+10K141768Logiq V5/Logiq V3GE Healthcare201457—
+10K141675Voluson P6, Voluson P8GE Healthcare201414—
+10K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+10K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+10K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+10K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+11K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+11K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+11K252332FolliscanMim Fertility20260—
+11K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+11K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+11K251456BrightHeart View ClassifierBrightheart20250—
+11K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+11K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+11K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+11K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+11K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+11K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+11K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—