Siui Sr-2100
by Shantou Institute of Ultrasonic Instruments Co., Ltd.
Siui Sr-2100 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 20 Dec 2021 (UDI-DI 06938396400439), 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 | Number06938396400439 | Date20 Dec 2021 | StatusListed |
| United States | FDA 510(k) | NumberK202353 | Date23 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 06938396400439
- FDA 510(k) database K202353
Across registries
- FDA 510(k) K202353 decided 23 Dec 2020 Active
- FDA GUDID UDI-DI 06938396400439 listed 20 Dec 2021 Listed
Timeline
- Cleared FDA 510(k) K202353
- Listed FDA GUDID 06938396400439
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- Withdrawn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-2100
- Primary DI / UDI-DI
- 06938396400439
- 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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