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 AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

About This 510(k) Submission

K250214 is an FDA 510(k) clearance for the 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 AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88), a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 20, 2025, 27 days after receiving the submission on January 24, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.