510(k) K230511

K3900 Ultrasound Imaging System by Maui Imaging — Product Code IYO

K230511 is an FDA 510(k) premarket notification submitted by Maui Imaging for the device "K3900 Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on October 25, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.