510(k) Report

Devices descending from K850478

276 later devices reach PLUS 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+8K182277Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20188—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics201828—
+8K173021Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine201818—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation2017221
+8K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.201792
+8K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+8K153489Cryocare CS Surgical SystemHealthtronics20165—
+8K151968Cryocare CS-3 Surgical System version 5Healthtronics20156—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+9K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+9K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+9K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+9K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+9K200655FibroScan® 630Echosens20200—
+9K200138Versana PremierGe Medical Systems Ultrasound And20202—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+9K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+9K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+9K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+9K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+9K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+9K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+9K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+9K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+9K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K250742Focused Cryotherapy SystemFocused Cryo, Inc.20250—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K2301796440 MyLabX90Esaote, S.p.A.202341
+10K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+10K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+10K220851VenueGE Medical Systems20223—
+10K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+10K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+10K200708Vivid iqGe Medical Systems Ultrasound And20203—
+10K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+10K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+10K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+10K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+10K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+10K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+10K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+10K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+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—
+10K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+11K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+11K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—