Shantou Institute of Ultrasonic Instruments (Siui: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instruments (Siui” (first 2006, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (5)
Most recent Shantou Institute of Ultrasonic Instruments (Siui 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K110841 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER | IYN | 2011-04-15 | 21 |
| K103144 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER | IYN | 2011-01-12 | 79 |
| K102023 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C | IYN | 2010-10-19 | 92 |
| K101008 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY | ITX | 2010-06-08 | 57 |
| K061488 | CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM | IYN | 2006-06-30 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Shantou Institute of Ultrasonic Instruments (Siui.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shantou Institute of Ultrasonic Instuments (11 510(k)s)
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (8 510(k)s)
- Shantou Wealy Medical Instrument Co.,Ltd (6 510(k)s)
- Shantou Institute of Ultrasonic Instruments Co., Ltd. (3 510(k)s)
- Shantou Xinghe Electrical Apparatuses Co., Ltd. (2 510(k)s)
- Shantou Huihengqi Electronic Technology Co., Ltd. (1 510(k)s)
- Shantou T&K Medical Equipment Factory Co.,Ltd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shantou Institute of Ultrasonic Instruments (Siui?
FDA lists 5 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instruments (Siui” (first 2006, latest 2011), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shantou Institute of Ultrasonic Instruments (Siui?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shantou Institute of Ultrasonic Instruments (Siui is 57 days.
Which FDA product codes appear under Shantou Institute of Ultrasonic Instruments (Siui?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 5 Shantou Institute of Ultrasonic Instruments (Siui clearances with predicates and recalls
- Run predicate analysis for product code IYN, Shantou Institute of Ultrasonic Instruments (Siui's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.