# Fcu Co., Ltd.

- Location (FDA's records): Yuseong-Gu, KR
- FDA decisions: 2 (2021–2024): 2 510(k) clearances
- Product codes: IYO (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Healcerion Co., Ltd.: 1 (https://510kreport.com/company/healcerion)

## Its most-cited devices
- K210468: SC1 Handheld Ultrasound Imaging System (Model: SC1) (2021), cited by 1

## Recent decisions
- K233579: SC1 Handheld Ultrasound Imaging system (Model: SC1) (Jun 26, 2024)
- K210468: SC1 Handheld Ultrasound Imaging System (Model: SC1) (Jul 23, 2021)

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