Triage Stroke 14.0
Triage Stroke 14.0 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K232496 on 21 Nov 2023 and listed in FDA GUDID since 18 Aug 2025 (UDI-DI B720BX360TRIAGESTRO1400), 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 | NumberB720BX360TRIAGESTRO1400 | Date18 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232496 | Date21 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K232496
Across registries
- FDA 510(k) K232496 decided 21 Nov 2023 Active
- FDA GUDID UDI-DI B720BX360TRIAGESTRO1400 listed 18 Aug 2025 Listed
Timeline
- Cleared FDA 510(k) K232496
- Listed FDA GUDID B720BX360TRIAGESTRO1400
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Triage Stroke
- Generic name
- X-ray image interpretive software
- Model / reference
- 14.0
- Primary DI / UDI-DI
- B720BX360TRIAGESTRO1400
- 510(k) Number
- FDA product code
- QAS
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2080
- GUDID distribution status
- In Commercial Distribution
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