510(k) Report

Devices descending from K142511

13 later devices reach U50 Diagnostic Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173003U50 Diagnostic Ultrasound SystemEdan Instruments, Inc.20171—
+1K172380U2 Diagnostic Ultrasound SystemEdan Instruments, Inc.20170—
+1K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20169—
+2K180408U60 Diagnostic Ultrasound SystemEdan Instruments, Inc.20180—
+2K162055Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20178—
+3K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20177—
+4K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.20183—
+4K171900Acclarix AX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20172—
+5K192879Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound…Edan Instruments, Inc.20201—
+5K192791Diagnostic Ultrasound SystemEdan Instruments, Inc.20191—
+5K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemEdan Instruments, Inc.20190—
+6K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—
+6K202856Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3…Edan Instruments, Inc.20210—