510(k) Report

Devices descending from K991611

1,015 later devices reach GE Logiq 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K181376Arietta 65Hitachi Healthcare Americas Corporation201831
+12K181098ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201819—
+12K180409HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201834—
+12K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+12K173555Logiq E10GE Healthcare2017382
+12K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens201715—
+12K172142FibroScan 430 Mini+Echosens20170—
+12K170521Trinity/3D Prostate SuiteKoelis20170—
+12K161047LOGIQ P9 and LOGIQ P7GE Healthcare2016107—
+12K160078Vivid T8Ge Medical Systems Ultrasound and Primary Care Diagnotics, L201618—
+12K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare2016551
+12K153037Logiq V1/ Logiq V2GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20160—
+12K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics201555—
+12K143601U-LiteSonoscanner Sarl20153—
+12K141768Logiq V5/Logiq V3GE Healthcare201457—
+12K141675Voluson P6, Voluson P8GE Healthcare201414—
+12K141067Vivid T8/Vivid T8 ProGE Healthcare201419—
+12K133761Aplio 500/400/300 Diagnostic Ultrasound System V4.0Toshibamedical Systems Corporation201472—
+12K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013255—
+12K131507Xario 200 Diagnostic Ultrasound SystemToshibamedical Systems Corporation20139—
+13K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K253949SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…CHISON Medical Technologies Co., Ltd.20260—
+13K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+13K252332FolliscanMim Fertility20260—
+13K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+13K251601Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K251456BrightHeart View ClassifierBrightheart20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…Esonic Technology (Wuhan) Co., Ltd.20250—
+13K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+13K242231Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K242223SuperSonic HepaVuSupersonic Imagine20240—
+13K241201TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20240—
+13K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+13K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd.20242—
+13K233841HD80 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+13K232908Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…Contec Medical Systems Co.,Ltd20240—
+13K233439HD60 Series Ultrasound Diagnostic SystemQingdao Hisense Medical Equipment Co., Ltd.20240—
+13K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)Eieling Technology Limited20242—
+13K231941ARIETTA x10FUJIFILM Healthcare Americas Corporation20230—
+13K232336ES Series V2E-Scopics20232—
+13K223920Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…Vinno Technology (Suzhou) Co.,Ltd20230—
+13K223287VelacurSonic Incytes20233—
+13K223830Ultrasound System 2300Bk Medical Aps202306
+13K223017Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0Canon Medical Systems Corporation20235—
+13K221093X-Cube 70, X-Cube 90Alpinion Medical Systems Co., Ltd.20220—
+13K220857X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20221—
+13K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+13K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K220619Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202222
+13K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202212—
+13K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20221—
+13K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics20223—
+13K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+13K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+13K212265TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20216—
+13K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+13K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+13K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+13K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+13K202658Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics20215—
+13K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+13K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+13K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+13K202422Arietta 65Hitachi Healthcare Americas20200—
+13K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+13K200138Versana PremierGe Medical Systems Ultrasound And20202—
+13K200585Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20208—
+13K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+13K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+13K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20193—
+13K192159Voluson E6, Voluson E8, Voluson E10GE Healthcare20195—
+13K191233Arietta 750Hitachi Healthcare Americas201901
+13K190248Arietta 50Hitachi Healthcare Americas20191—
+13K182632HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20191—
+13K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+13K171164U-Lite EXPSonoscanner20172—
+13K163596LOGIQ P9 and LOGIQ P7GE Healthcare201747—
+13K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC201611—
+13K160162Voluson P6, Voluson P8GE Healthcare201613—
+13K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015187—
+13K143027Xario 200, V3.0Toshibamedical Systems Corporation201451
+13K142517SoftVueDelphinus Medical Technologies, Inc.201449—
+13K133277XARIO 100Toshibamedical Systems Corporation20142—
+14K262390BoneXpertVisiana20260—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K260589ES-SeriesE-Scopics20260—
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K253049Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—