510(k) Report

Devices descending from K172385

22 later devices reach Clarius Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191235Leltek Ultrasound Imaging SystemLeltek, Inc.20209—
+1K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+2K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+2K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+3K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+3K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+3K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+3K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+3K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+3K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+3K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+3K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+4K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+4K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+4K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+4K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+4K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+4K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+5K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+5K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+5K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+6K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—