510(k) K222365

Leltek Ultrasound Imaging System (Model: LU700 Series) by Leltek, Inc. — Product Code IYN

K222365 is an FDA 510(k) premarket notification submitted by Leltek, Inc. for the device "Leltek Ultrasound Imaging System (Model: LU700 Series)". The FDA issued a decision of Substantially Equivalent on October 25, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Leltek, Inc. has at least 4 other 510(k) clearances on record.