510(k) K163688

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 by Medisono, LLC — Product Code IYN

K163688 is an FDA 510(k) premarket notification submitted by Medisono, LLC for the device "Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Medisono, LLC has at least 2 other 510(k) clearances on record.