510(k) Report

Devices descending from K080234

84 later devices reach Terason Echo T/3000 Ultrasound System with Stress Echo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274—
+1K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114—
+1K110020Terason T3200 Ultrasound SystemTeratech Corp.201113—
+2K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc.20186—
+2K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+2K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+2K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+2K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+2K140254EZONO 4000Ezono AG201413—
+2K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+3K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+3K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.20205—
+3K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+3K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+3K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+3K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+3K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+4K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+4K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20214—
+4K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+4K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+4K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+4K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+4K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+4K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+4K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+4K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+4K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+4K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+4K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+4K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+4K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+5K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+5K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+5K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+5K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20223—
+5K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+5K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+5K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+5K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+5K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+5K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+5K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+6K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+6K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+6K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.20232—
+6K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+6K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+6K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+6K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+6K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+6K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+6K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+7K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+7K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20241—
+7K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+7K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+7K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+7K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+7K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+7K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion 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—
+7K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+7K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+7K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+8K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+8K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.20250—
+8K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+8K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+8K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+8K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+8K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+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—
+9K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+9K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+10K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+10K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—