Shantou Institute of Ultrasonic Instuments: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instuments” (first 1997, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 164 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 | 1 | 192 |
| 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 8 | 8 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
Review panels
- Radiology (11)
Most recent Shantou Institute of Ultrasonic Instuments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113613 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM | IYN | 2012-06-15 | 192 |
| K092907 | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR | IYN | 2010-03-05 | 164 |
| K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | 2008-05-16 | 28 |
| K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | IYO | 2007-05-02 | 26 |
| K061083 | CTS-7700 | IYO | 2006-06-06 | 49 |
| K013327 | CTS-415 | IYO | 2001-12-14 | 70 |
| K012772 | CTS-485 ULTRASOUND IMAGING SYSTEM | IYO | 2001-10-01 | 45 |
| K984203 | SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM | IYN | 1999-11-01 | 342 |
| K984161 | CTS-310(B) | IYO | 1999-05-05 | 166 |
| K963068 | CTS-200 WITH EZU-PL21 TRANSDUCER | IYO | 1997-05-29 | 295 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shantou Institute of Ultrasonic Instuments.
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 Instruments Co., Ltd. (Siui) (8 510(k)s)
- Shantou Wealy Medical Instrument Co.,Ltd (6 510(k)s)
- Shantou Institute of Ultrasonic Instruments (Siui (5 510(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 Instuments?
FDA lists 11 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instuments” (first 1997, latest 2012), 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 Instuments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shantou Institute of Ultrasonic Instuments is 164 days.
Which FDA product codes appear under Shantou Institute of Ultrasonic Instuments?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 8); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3).
Next steps
- See all 11 Shantou Institute of Ultrasonic Instuments clearances with predicates and recalls
- Run predicate analysis for product code IYO, Shantou Institute of Ultrasonic Instuments'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.