# Leltek, Inc.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 5 (2020–2025): 5 510(k) clearances
- Product codes: IYN (5)
- 510(k) review time since 2016: median 212 days, against 105 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 8 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Clarius Mobile Health Corp.: 1 (https://510kreport.com/company/clarius-mobile-health)

## Firms that cite its devices most
- Nurodata, Inc.: 1 (https://510kreport.com/company/nurodata)
- Asustek Computer, Inc.: 1 (https://510kreport.com/company/asustek-computer)
- Imgfax CO., LTD.: 1 (https://510kreport.com/company/imgfax)
- Healium Intelliscan Corporation: 1 (https://510kreport.com/company/healium-intelliscan)

## Its most-cited devices
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series) (2022), cited by 3
- 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 (2024), cited by 2
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series) (2021), cited by 1
- K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (2025), cited by 1
- K191235: Leltek Ultrasound Imaging System (2020), cited by 1

## Recent decisions
- K243226: Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (May 8, 2025)
- 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 (Sep 11, 2024)
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series) (Oct 25, 2022)
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series) (Nov 3, 2021)
- K191235: Leltek Ultrasound Imaging System (Feb 12, 2020)

Source page: https://510kreport.com/company/leltek