510(k) Report

Devices descending from K914945

122 later devices reach Diagnostic Ultrasound System Type 3535, Modified through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992505Teratech, Model 2000 Imaging ImagingTeratech Corp.1999109—
+1K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity…CIVCO Medical Instruments Co., Inc.19991—
+1K980997PGK Device (Modified)Pgk, Inc.19980—
+1K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.19971—
+1K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Barzell-Whitmore Maroon Bells, Inc.19976—
+2K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc.20131—
+2K080119ClearscanEsi, Inc.20080—
+2K072266Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20071—
+2K070907Interson Usb Ultrasound Probe SystemRegulatory Management Services2007106—
+2K023430UF Brachytherapy StandUniversity of Florida20030—
+2K024183Alton PT StepperAlton Design, LLC20030—
+2K982696InterplantBurdette Medical Systems, Inc.199911
+2K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.19980—
+3K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+3K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis20170—
+3K163443Interson USB Ultrasound SystemInterson Corporation20173—
+3K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group20160—
+3K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+3K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2014873
+3K131428RadvisionAcoustic Medsystems, Inc.20130—
+3K102153Mobius Ultrasound Imaging SystemMobisante, Inc.2011103—
+3K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc.20090—
+3K080049Vascuview Ultrasound SystemEscalon Medical Corp.20080—
+4K233734Interson USB Ultrasound SystemInterson Corporation20230—
+4K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+4K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+4K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd.201533—
+4K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+4K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC20145—
+5K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+5K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K192388SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC20200—
+5K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd.20184—
+5K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+5K171594AccuroRivanna Medical, LLC20173—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K162549Lumify Ultrasound SystemPhilips Health Care2016436
+5K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+5K160420SpeqTSignostics Limited20161—
+6K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd.20260—
+6K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+6K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+6K243937Accuro 3SRivanna Medical, Inc.20252—
+6K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+6K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+6K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd.20221—
+6K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd.20220—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+6K181574UscanEchoNous, Inc.20180—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+6K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+6K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+7K253452Accuro 3SRivanna Medical, Inc.20260—
+7K254021Accuro XVRivanna Medical, Inc.20260—
+7K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+7K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+7K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+7K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+7K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+7K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+8K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+8K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+8K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+8K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+8K211527Exo IrisExo Imaging, Inc.20211—
+8K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+9K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+9K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+9K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+9K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+9K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+9K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+10K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—