# Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

- Location (FDA's records): Shantou, CN
- FDA decisions: 8 (2016–2021): 8 510(k) clearances
- Product codes: IYN (4), IZL (4)
- 510(k) review time since 2016: median 124 days, against 52 for FDA's reviews in the same codes and years (1 of 8 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 9 (3 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
- Radmedix, LLC: 2 (https://510kreport.com/company/radmedix)
- Minxray, Inc.: 2 (https://510kreport.com/company/minxray)
- Shantou Institute of Ultrasonic Instuments: 1 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instuments)
- Shantou Institute of Ultrasonic Instruments (Siui: 1 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instruments-siui)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Shantou Institute of Ultrasonic Instruments Co., Ltd.: 3 (https://510kreport.com/company/shantou-institute-of-ultrasonic-instruments)
- Shenzhen Browiner Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-browiner-tech)
- Ecoray Co., Ltd.: 1 (https://510kreport.com/company/ecoray)
- Yian Medical Technology (Haining) Co., Ltd.: 1 (https://510kreport.com/company/yian-medical-technology-haining)

## Its most-cited devices
- K173000: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (2017), cited by 3
- K202353: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (2020), cited by 2
- K160853: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System (2016), cited by 2
- K200976: SR-8230, SR-8230S Portable X-ray Unit (2020), cited by 1
- K200637: SR-8100 Portable X-ray Unit (2020), cited by 1

## Recent decisions
- K210317: Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System (Aug 19, 2021)
- K210318: Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System (Aug 18, 2021)
- K202350: SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System (Jan 6, 2021)
- K202353: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System (Dec 23, 2020)
- K200637: SR-8100 Portable X-ray Unit (Jul 9, 2020)
- K200976: SR-8230, SR-8230S Portable X-ray Unit (Jun 10, 2020)
- K173000: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (Dec 7, 2017)
- K160853: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System (Jun 27, 2016)

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