e-MRI 11.1
e-MRI 11.1 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K231656 on 30 Aug 2023 and listed in FDA GUDID since 5 Sep 2023 (UDI-DI B720BX360EMRI1110), active as of 23 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 | NumberB720BX360EMRI1110 | Date5 Sep 2023 | StatusListed |
| United States | FDA 510(k) | NumberK231656 | Date30 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K231656
Across registries
- FDA 510(k) K231656 decided 30 Aug 2023 Active
- FDA GUDID UDI-DI B720BX360EMRI1110 listed 5 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K231656
- Listed FDA GUDID B720BX360EMRI1110
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- e-MRI
- Generic name
- X-ray image interpretive software
- Model / reference
- 11.1
- Primary DI / UDI-DI
- B720BX360EMRI1110
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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