Siui Sr-2300S
by Shantou Institute of Ultrasonic Instruments Co., Ltd.
Siui Sr-2300S is a Class II device made by Shantou Institute of Ultrasonic Instruments Co., Ltd., cleared under FDA 510(k) K202353 on 23 Dec 2020 and listed in FDA GUDID since 9 Jan 2021 (UDI-DI 06938396423025), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06938396423025 | Date9 Jan 2021 | StatusListed |
| United States | FDA 510(k) | NumberK202353 | Date23 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 06938396423025
- FDA 510(k) database K202353
Across registries
- FDA 510(k) K202353 decided 23 Dec 2020 Active
- FDA GUDID UDI-DI 06938396423025 listed 9 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K202353
- Listed FDA GUDID 06938396423025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Siui
- Generic name
- Portable basic diagnostic x-ray system, digital
- Model / reference
- SR-2300S
- Primary DI / UDI-DI
- 06938396423025
- 510(k) Number
- FDA product code
- IZL, MQB, LLZ
- GMDN term
- Portable basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1720, 892.1680, 892.2050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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