510(k) Report

Devices descending from K994096

196 later devices reach Sonoheart Hand-Carried Echocardiography System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K253452Accuro 3SRivanna Medical, Inc.20260—
+7K252558Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+7K254021Accuro XVRivanna Medical, Inc.20260—
+7K252557Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+7K251402LIA-1 Catheter (542-1)Leadoptik, Inc.20250—
+7K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.20250—
+7K234153EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…Edgelife Technologies, LLC20240—
+7K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.20240—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K233734Interson USB Ultrasound SystemInterson Corporation20230—
+7K231354Pocket Ultrasound System (C10)Beijing Konted Medical Technology Co.,Ltd20232—
+7K232500Lumify Diagnostic Ultrasound SystemPhilips Ultrasound202301
+7K231301Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20231—
+7K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.20231—
+7K213060AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound…Micro-Tech (Nanjing) Co., Ltd.20221—
+7K221148Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20222—
+7K220446Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+7K212100KosmosEchoNous, Inc.202101
+7K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc.20200—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K200851Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20202—
+7K200998Versana ActiveGE Medical Systems Ultrasound and Primary Care Diagnostics20200—
+7K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+7K192170VistaScan USB Ultrasound Imaging SystemEmagine Solutions Technology, LLC20200—
+7K190239Single Use Aspiration NeedleOlympus Medical Systems Corp.20192—
+7K192573Dolphin Medical Imaging USB Ultrasound SystemDolphin Medical Imaging, LLC20190—
+7K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care2019315
+7K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+7K163510Poseidon Ultrasound SystemButterfly Network, Inc.201762
+7K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+8K251478ClearTip TBNA TypeFinemedix Co., Ltd.20260—
+8K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems Corporation20250—
+8K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.20250—
+8K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound20250Class I
+8K250087Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K243620Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+8K241979Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)Beijing Konted Medical Technology Co.,Ltd20241—
+8K230778EndoCorePraxis Medical, LLC20230—
+8K223407Versana EssentialGE Medical Systems Ultrasound and Primary Care Diagnostics20230—
+8K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics20221—
+8K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+8K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital…CHISON Medical Technologies Co., Ltd.20210—
+8K201967SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound SystemCHISON Medical Technologies Co., Ltd.20210—
+8K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.202143
+8K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc.20205—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+8K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+9K261081Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)Beijing Konted Medical Technology Co.,Ltd20260—
+9K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+9K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc.20250—
+9K243628Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+9K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc.20232—
+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—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+9K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+9K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+10K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+10K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+10K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+10K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+10K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+11K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+11K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+12K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+13K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+13K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+14K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+14K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+14K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+15K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—