510(k) Report

Devices descending from K153626

42 later devices reach SonoSite Edge II Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163138Clarius Ultrasound SystemClarius Mobile Health Corp.201628—
+1K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc.201611—
+1K160734SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.201612—
+2K233597Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20233—
+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—
+2K183235SonoSite SII Ultrasound SystemFUJIFILM Sonosite, Inc.20191—
+2K180704SonoSite iViz Ultrasound SystemFUJIFILM Sonosite, Inc.20182—
+2K173138Biim Diagnostic Ultrasound SystemBiim Ultrasound AS20170—
+2K170085SONON Ultrasound Imaging System, Model: 300LHealcerion Co., Ltd.20174—
+2K172385Clarius Ultrasound SystemClarius Mobile Health Corp.201722—
+2K171437SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.20177—
+3K260595Sonosite iLOOK Ultrasound SystemFUJIFILM Sonosite, Inc.20260—
+3K251106Sonosite LX and Sonosite PX Ultrasound SystemsFUJIFILM Sonosite, Inc.20250—
+3K251830Sonosite LX Ultrasound SystemFUJIFILM Sonosite, Inc.20251—
+3K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd.20220—
+3K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+3K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)Fcu Co., Ltd.20211—
+3K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+3K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+4K253448Sonosite MT Ultrasound SystemFUJIFILM Sonosite, Inc.20250—
+4K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.20240—
+4K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+4K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+5K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+5K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+5K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+5K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+5K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+5K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+5K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+6K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+6K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+6K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+6K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+6K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+6K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+7K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+7K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+7K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+8K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—