510(k) Report

Devices descending from K120321

91 later devices reach Clearvue 350/550 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+1K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+1K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K163020Xperius Ultrasound SystemPhilips Health Care201611
+2K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+2K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+3K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+3K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+3K163443Interson USB Ultrasound SystemInterson Corporation20173—
+3K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+3K162549Lumify Ultrasound SystemPhilips Health Care2016436
+3K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+3K160420SpeqTSignostics Limited20161—
+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
+4K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+4K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+4K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+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
+4K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+5K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+5K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+5K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+5K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+5K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+5K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+5K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+5K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+5K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+5K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+5K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+5K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+5K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+5K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+6K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+6K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+6K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+6K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+6K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+6K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+6K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+6K211527Exo IrisExo Imaging, Inc.20211—
+6K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+6K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+7K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+7K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+7K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+7K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+7K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+7K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+7K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+8K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+8K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+8K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+8K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+8K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+8K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+8K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+8K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+9K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+9K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+9K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+9K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+9K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+9K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+9K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+10K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+10K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+10K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+11K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+11K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—