510(k) K243226

Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) by Leltek, Inc. — Product Code IYN

K243226 is an FDA 510(k) premarket notification submitted by Leltek, Inc. for the device "Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)". The FDA issued a decision of Substantially Equivalent on May 8, 2025. 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.