Chrysalis Intelligence · Sponsors · Leltek, Inc.

Leltek, Inc.

New Taipei City, TW · 5 510(k) clearances

Total clearances
5
2020-02-12 → 2025-05-08
Last 12 months
0
Product codes
1
Most recent
2025-05-08
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 5 2025-05-08
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-05-08 K243226 Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) IYN Class II Radiology
2024-09-11 K241161 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 Imaging IYN Class II Radiology
2022-10-25 K222365 Leltek Ultrasound Imaging System (Model: LU700 Series) IYN Class II Radiology
2021-11-03 K210432 LELTEK Ultrasound Imaging System (Model: LU700 Series) IYN Class II Radiology
2020-02-12 K191235 Leltek Ultrasound Imaging System IYN Class II Radiology