510(k) K192879

Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System by Edan Instruments, Inc. — Product Code IYN

K192879 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on May 21, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Edan Instruments, Inc. has 93 other 510(k) clearances on record.