510(k) Report

Devices descending from K862127

276 later devices reach Dymax Personal Scanner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation2016231
+7K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L201646—
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+7K141110Cryocare CS Surgical SystemHealthtronics20157—
+8K253452Accuro 3SRivanna Medical, Inc.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K254021Accuro XVRivanna Medical, Inc.20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K251673X9 Ultrasound SystemX9, Inc.20250—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc.20240—
+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
+8K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+8K211886Clivia series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20211—
+8K211527Exo IrisExo Imaging, Inc.20211—
+8K202132VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20207—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K200655FibroScan® 630Echosens20200—
+8K200138Versana PremierGe Medical Systems Ultrasound And20202—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+8K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+8K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+8K183362Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics2019142
+8K181727Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20189—
+8K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+8K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+8K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017102
+8K170847EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20174—
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+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—
+9K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+9K2301796440 MyLabX90Esaote, S.p.A.202341
+9K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+9K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222—
+9K220851VenueGE Medical Systems20223—
+9K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K210438Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics20211—
+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
+9K203137Venue FitGE Medical Systems Ultrasound and Primary Care Diagnostics202051
+9K202233Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics202042
+9K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+9K200708Vivid iqGe Medical Systems Ultrasound And20203—
+9K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+9K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc.20204—
+9K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+9K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+9K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+9K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+9K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+9K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+9K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics201892
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+10K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+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—
+10K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20251—
+10K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+10K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+10K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+10K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+10K242005Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics202402
+10K240111VenueGE Medical Systems Ultrasound and Primary Care Diagnostics20242—
+10K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd.20230—
+10K230271ISOLIS CryoprobeVarian Medical Systems, Inc.20231—
+10K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+10K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+10K220848Venue FitGE Medical Systems202241