510(k) Report

Devices descending from K112953

74 later devices reach Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.20152—
+1K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.20150—
+1K140834Terason USMART3400 Ultrasound SystemTeratech Corp.20140—
+1K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp.20143—
+1K140254EZONO 4000Ezono AG201413—
+1K131209Terason USMART3200T Ultrasound SystemTeratech Corp.20134—
+1K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.2013521
+2K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+2K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation20201—
+2K190120Vinno 8, Vinno 6, Vinno 5Vinno Technology (Suzhou) Co.,Ltd20201—
+2K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+2K172059LinkQuest Diagnostic Ultrasound System model SQ860Linkquest, Inc.20170—
+2K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+2K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.201350—
+3K221911Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPVinno Technology (Suzhou) Co.,Ltd20220—
+3K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation20200—
+3K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20199—
+3K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+3K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+3K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+3K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+3K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+3K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+3K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+3K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+3K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+3K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+4K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+4K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+4K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+4K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+4K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+4K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20208—
+4K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+4K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+4K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+5K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+5K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+5K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+5K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20214—
+5K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20211—
+5K202556HS30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+5K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+5K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+5K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+6K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+6K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+6K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+6K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+6K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+6K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+6K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+6K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+6K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+6K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+6K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+6K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+6K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+7K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+7K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+7K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+7K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+7K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+7K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+7K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+7K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+8K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+8K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+8K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+8K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+9K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+9K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—