510(k) Report

Devices descending from K043535

130 later devices reach HD11 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120321Clearvue 350/550 Diagnostic Ultrasound SystemPhilips Health Care2012918
+1K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20115610
+1K081802CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2008574
+1K081661HD15 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2008025
+2K153480ClearVue850 Diagnostic Ultrasound SystemPhilips Health Care2015210
+2K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+2K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+2K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps20140—
+2K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps20140—
+2K123754CX50 3.0 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20125322
+3K163020Xperius Ultrasound SystemPhilips Health Care201611
+3K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care2016273
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+3K142714S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited20154—
+3K142710S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Company Limited201519—
+4K250030Flash Ultrasound System 5100 Point of CarePhilips Ultrasound, LLC202505
+4K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+4K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+4K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+4K192254InnoSight Diagnostic Ultrasound SystemQisda Corporation20190—
+4K182529Xperius Ultrasound SystemPhilips Ultrasound, Inc.20180—
+4K172056InnoSight Diagnostic Ultrasound SystemQisda Corporation20172—
+4K163443Interson USB Ultrasound SystemInterson Corporation20173—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+4K162549Lumify Ultrasound SystemPhilips Health Care2016436
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160420SpeqTSignostics Limited20161—
+4K152164S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20153—
+4K152165S9 Portable Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201502
+4K150045S30/S40 Digital Color Doppler Ultraound SystemSonoscape Company Limited201517—
+5K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+5K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+5K233734Interson USB Ultrasound SystemInterson Corporation20230—
+5K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+5K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+5K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+5K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+5K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+5K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+5K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+5K181313BenQ Diagnostic Ultrasound SystemQisda Corporation20181—
+5K181574UscanEchoNous, Inc.20180—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+5K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+5K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+5K160258X5 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20162—
+5K152854S50 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201616—
+6K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+6K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+6K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+6K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+6K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+6K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+6K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+6K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+6K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+6K170303E5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+6K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20170—
+6K160283S45 Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.201615—
+7K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+7K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+7K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+7K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+7K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+7K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+7K211527Exo IrisExo Imaging, Inc.20211—
+7K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+7K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+7K172082S60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20175—
+7K170999P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+7K171000P60 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20174—
+8K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+8K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+8K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+8K241949Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp.20250—
+8K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+8K231659MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…Medisono20240—
+8K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+8K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+8K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+8K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+8K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+8K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+8K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—