510(k) Report

Devices descending from K192879

1 later device reach Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…Edan Instruments, Inc.20250—