Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Shantou, CN
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) appears in FDA device records in Shantou, CN. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) between 2016 and 2021. The busiest year on record is 2020, with 3. The most recent is 2021, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 3 |
| 2021 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | |
| K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | |
| K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | IZL | Substantially Equivalent | |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | IZL | Substantially Equivalent | |
| K200637 | SR-8100 Portable X-ray Unit | IZL | Substantially Equivalent | |
| K200976 | SR-8230, SR-8230S Portable X-ray Unit | IZL | Substantially Equivalent | |
| K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent | |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | IYN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain