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Leltek, Inc. FDA Approvals
0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)510(k)May 8, 2025Radiology |
| Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging510(k)Sep 11, 2024Radiology |
| Leltek Ultrasound Imaging System (Model: LU700 Series)510(k)Oct 25, 2022Radiology |
| LELTEK Ultrasound Imaging System (Model: LU700 Series)510(k)Nov 3, 2021Radiology |