510(k) Report

Devices descending from K002258

399 later devices reach Ultraguide CT-Guide 1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200655FibroScan® 630Echosens20200—
+5K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.20200—
+5K201053PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc.20201—
+5K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+5K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+5K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+5K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+5K181124Acessa ProVu SystemAcessa Health, Inc.20180—
+5K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+5K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+5K1732916440 Ultrasound SystemEsaote, S.p.A.20188—
+5K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Toshibamedical Systems Corporation201821—
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+5K171677Clear Guide SCENERGYClear Guide Medical20173—
+5K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+5K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+5K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+5K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+5K171022Ablation ConfirmationNeuwave Medical, Inc.20172—
+5K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20179—
+5K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+5K163020Xperius Ultrasound SystemPhilips Health Care201611
+5K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+5K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+5K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+5K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+5K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+5K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+5K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+5K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+5K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+5K121449DirectpathCybernet Systems Co., Ltd.20120—
+5K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc.20113—
+5K093423Lungpoint Procedure PlanningBroncus Technologies, Inc.20091—
+5K062315Superdimension/Bronchus Premium 2Superdimension, Ltd.2006541
+6K253264myAblation Guide (VC10A)Siemens Healthcare GmbH20260—
+6K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K240773VisAble.IOTechsomed20241—
+6K2301796440 MyLabX90Esaote, S.p.A.202341
+6K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+6K223804PercuNav Image Fusion and Interventional Navigation SystemPhilips Ultrasound, LLC20230—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+6K201188Clear Guide SCENERGYClear Guide Medical20201—
+6K201898Clear Guide SCENERGYClear Guide Medical20200—
+6K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+6K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+6K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+6K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+6K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K1921576450 Ultrasound systemEsaote, S.p.A.20194—
+6K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+6K192427Ablation ConfirmationNeuwave Medical, Inc.20191—
+6K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+6K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K181637DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20198—
+6K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+6K1831916420 Ultrasound SystemEsaote, S.p.A.20180—
+6K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20184—
+6K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1Canon Medical Systems Corporation201810—
+6K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+6K181892Ziostation2Ziosoft, Inc.20181—
+6K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+6K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+6K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+6K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+6K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+6K163443Interson USB Ultrasound SystemInterson Corporation20173—
+6K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K162549Lumify Ultrasound SystemPhilips Health Care2016436
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+6K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+6K160420SpeqTSignostics Limited20161—
+6K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+6K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+6K071473Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd.200753—
+7K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251931BioTraceIO Vision (V1.7)Techsomed Medical Technologies20250—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote, S.p.A.20252—
+7K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A.20252—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+7K232227Ablate-IQNeuwave Medical, Inc.20240—
+7K234030Clear Guide SCENERGYClear Guide Medical20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—