# Shantou Institute of Ultrasonic Instruments Co., Ltd.

- Location (FDA's records): Shantou, CN
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: IYN (2), IZL (1)
- 510(k) review time since 2016: median 182 days, against 124 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 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
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui): 3 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instruments-co-siui)

## Recent decisions
- K253058: Portable DR Imaging System (Jun 18, 2026)
- K243178: Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (Mar 31, 2025)
- K243132: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (Dec 10, 2024)

Source page: https://510kreport.com/company/shantou-institute-of-ultrasonic-instruments