510(k) K170078

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley by Medisono, LLC — Product Code IYN

K170078 is an FDA 510(k) premarket notification submitted by Medisono, LLC for the device "Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley". The FDA issued a decision of Substantially Equivalent on May 17, 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.