FDA 510(k) Applications Submitted by Edan Instruments Inc.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K161300	05/09/2016	Acclarix AX8 Diagnostic Ultrasound System	EDAN INSTRUMENTS INC.
K250214	01/24/2025	Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix	Edan Instruments Inc.