510(k) Report

Devices descending from K133454

50 later devices reach Sonosite Edge Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+1K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+1K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+1K162288SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20163—
+1K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+1K161119SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20164—
+1K160406FUJIFILM FC1 Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+1K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201642—
+1K152983FUJIFILM SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20155—
+1K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201545—
+1K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.201446—
+2K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+2K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+2K220983ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemImsonic Medical China, Inc.20220—
+2K213763Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20214—
+2K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+2K200964Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc.20206—
+2K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+2K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+2K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+2K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+2K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+3K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+3K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+3K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+3K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+3K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+3K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+4K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+4K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+4K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+4K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+4K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+4K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+4K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+4K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+4K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+4K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+4K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+5K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+5K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+5K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+5K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+5K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+5K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+5K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+6K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+6K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+6K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+7K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—