Leltek, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
1
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound ImagingMay 8, 2025
K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (September 11, 2024
K222365Leltek Ultrasound Imaging System (Model: LU700 Series)October 25, 2022
K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)November 3, 2021
K191235Leltek Ultrasound Imaging SystemFebruary 12, 2020