510(k) Report

Devices descending from K132304

211 later devices reach Epiq Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50…Philips Ultrasound, Inc.20175828
+1K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc.201610033
+1K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+1K150773E-CUBE 15 Diagnostic Ultrasound SystemAlpinion Medical Systems Co., Ltd.201515—
+1K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+1K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+1K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+1K142815S22 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20152—
+1K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+1K142474S12 Digital Color Doppler Ultrasound SystemSonoscape Company Limited20144—
+1K140808Q-StationPhilips Ultrasound, Inc.201402
+1K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K260123EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202601
+2K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+2K182594E-CUBE i7Alpinion Medical Systems Co., Ltd.20191—
+2K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+2K181277E-CUBE 12Alpinion Medical Systems Co., Ltd.20187—
+2K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20…Supersonic Imagine201816—
+2K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+2K171926C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.20171—
+2K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+2K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.20170—
+2K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12…Medisono, LLC20170—
+2K163690DC-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—
+2K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201720—
+2K163020Xperius Ultrasound SystemPhilips Health Care201611
+2K161439E-CUBE 11Alpinion Medical Systems Co., Ltd.201612—
+2K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+2K153424E-CUBE i7Alpinion Medical Systems Co., Ltd.201614—
+2K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+2K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+2K152396S12 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20151—
+2K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+2K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+2K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+2K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+3K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+3K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+3K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+3K213523X-CUBE i8, X-CUBE i9Alpinion Medical Systems Co., Ltd.20220—
+3K200449X-Cube 90Alpinion Medical Systems Co., Ltd.20204—
+3K200450X-Cube 70Alpinion Medical Systems Co., Ltd.20204—
+3K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+3K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+3K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+3K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsSupersonic Imagine20195—
+3K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+3K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation20199—
+3K181637DC-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—
+3K182845minisonoAlpinion Medical Systems Co., Ltd.20180—
+3K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+3K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+3K173471DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd.20181—
+3K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+3K171891ZS3 Ultrasound System, z.one pro Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20174—
+3K171034M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201712—
+3K163443Interson USB Ultrasound SystemInterson Corporation20173—
+3K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+3K162549Lumify Ultrasound SystemPhilips Health Care2016436
+3K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+3K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+3K160420SpeqTSignostics Limited20161—
+3K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+4K261272ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…Esonic Technology (Wuhan) Co., Ltd.20260—
+4K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+4K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+4K233734Interson USB Ultrasound SystemInterson Corporation20230—
+4K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+4K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+4K230066Carnation series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co., Ltd.20230—
+4K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+4K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+4K211300X-CUBE 90Alpinion Medical Systems Co., Ltd.20213—
+4K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.20213—
+4K203645Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC…Supersonic Imagine20212—
+4K210416M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20212—
+4K202455Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc…Supersonic Imagine20200—
+4K202737Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and…Canon Medical Systems Corporation20200—
+4K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1Canon Medical Systems Corporation20207—
+4K200001MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20208—
+4K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+4K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+4K192410ZS3 and z.one pro Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd.20193—
+4K192152DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20196—
+4K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+4K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+4K190206DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20190—
+4K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+4K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+4K181574UscanEchoNous, Inc.20180—
+4K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+4K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+4K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+4K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+4K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+4K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+4K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+5K251820ViewMateTM Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I