510(k) Report

Devices descending from K033650

945 later devices reach Acunav 90/10 Diagnostic Ultrasound Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+13K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+13K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+13K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+13K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+13K260217AI Platform 2.2 (AIP002)Exo Imaging20260—
+13K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+13K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+13K250024TE Air Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+13K243684BrightHeart View ClassifierBrightheart20251—
+13K243862LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K243235LVivo Software ApplicationDia Imaging Analysis, Ltd.20250—
+13K241222Ventripoint Medical System Plus (VMS+) 4.0Ventripoint Diagnostics, Ltd.20250—
+13K240645Sonix HealthOntact Health Co., Ltd.20240—
+13K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—
+13K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+13K241051Vave Wireless Ultrasound SystemVave Health, Inc.20240—
+13K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+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
+13K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+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—
+13K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+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—
+13K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+13K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+13K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+13K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+13K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20222—
+13K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+13K212012Follicle ClarityCycle Clarity20221—
+13K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+13K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+13K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmGe Medical Systems, LLC20211—
+13K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+13K211527Exo IrisExo Imaging, Inc.20211—
+13K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+13K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+13K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+13K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics202132
+13K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+13K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+13K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+13K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+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—
+13K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+13K202422Arietta 65Hitachi Healthcare Americas20200—
+13K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+13K201768Voluson E10GE Healthcare20204—
+13K2013523D Auto LAAPhilips Health Care20200—
+13K200743Vivid E80/ Vivid E90/ Vivid E95Ge Medical Systems Ultrasound And20207—
+13K200138Versana PremierGe Medical Systems Ultrasound And20202—
+13K200356Medo AriaMedo.Ai20203—
+13K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+13K200158Logiq E10GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC202012—
+13K200119LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics20209—
+13K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+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—
+13K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+13K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertGE Healthcare201821
+13K171594AccuroRivanna Medical, LLC20173—
+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—
+14K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics20260—
+14K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+14K260589ES-SeriesE-Scopics20260—
+14K252332FolliscanMim Fertility20260—
+14K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC20260—
+14K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+14K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited20260—