510(k) Report

Devices descending from K990806

232 later devices reach C1 Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K152922ViziShot FLEXSpiration, Inc.20166—
+6K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+6K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc.2015794
+6K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+6K141369Visiq Diagnostic Ultra Sound SystemPhilips Ultrasound, Inc.20140—
+6K133763Sonotip Pro and Pro Flex Ebus-Tbna Needle SystemMedi-Globe Corporation20142—
+6K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company201434
+6K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+7K250145Biopsy Port AdapterEndosound, Inc.20250—
+7K250331Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd.20250—
+7K230986Bladder ScannerAvantsonic Technology Co., Ltd.20230—
+7K231267ClearTipFinemedix Co., Ltd.20231—
+7K223771Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202322
+7K214089FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2Fujifilm Corporation20220—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+7K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+7K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd.202121
+7K202035Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20203—
+7K200708Vivid iqGe Medical Systems Ultrasound And20203—
+7K193518KosmosEchoNous, Inc.20201—
+7K193517ViziShot 2 FLEXOlympus Surgical Technologies America20202Class I
+7K190669EndoticsEra Endoscopy S.R.L.20200—
+7K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.20191—
+7K191798Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20191—
+7K191792Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20193—
+7K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc.20190—
+7K183085CoreDx™ Pulmonary Mini-ForcepsBoston Scientific Corporation20190—
+7K181934Vivid T8, Vivid T9GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20183—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+7K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd.20170—
+7K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+7K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+7K163443Interson USB Ultrasound SystemInterson Corporation20173—
+7K163469ViziShot 2 FLEXOlympus Surgical Technologies America20175—
+7K162549Lumify Ultrasound SystemPhilips Health Care2016436
+7K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+8K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip…Cook Ireland, Ltd.20260—
+8K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+8K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+8K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+8K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+8K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+8K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K233734Interson USB Ultrasound SystemInterson Corporation20230—
+8K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+8K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+8K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+8K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+8K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+8K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+8K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K212100KosmosEchoNous, Inc.202101
+8K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+8K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+8K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+8K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+8K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+8K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+8K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+8K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+8K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+8K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+9K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+9K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+9K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+9K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+9K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+9K230778EndoCorePraxis Medical, LLC20230—
+9K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+9K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+9K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+9K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+9K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+10K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+10K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+10K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+10K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+10K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K211527Exo IrisExo Imaging, Inc.20211—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—