e-ASPECTS 11.3
e-ASPECTS 11.3 is a Class II device made by Brainomix Limited, cleared under FDA 510(k) K243294 on 14 Feb 2025 and listed in FDA GUDID since 15 Apr 2025 (UDI-DI B720BX360EASPECTS113), 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 | NumberB720BX360EASPECTS113 | Date15 Apr 2025 | StatusListed |
| United States | FDA 510(k) | NumberK243294 | Date14 Feb 2025 | StatusActive |
Official records
- FDA 510(k) database K243294
Across registries
- FDA 510(k) K243294 decided 14 Feb 2025 Active
- FDA GUDID UDI-DI B720BX360EASPECTS113 listed 15 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K243294
- Listed FDA GUDID B720BX360EASPECTS113
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- e-ASPECTS
- Generic name
- X-ray image interpretive software
- Model / reference
- 11.3
- Primary DI / UDI-DI
- B720BX360EASPECTS113
- 510(k) Number
- FDA product code
- POK
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2060
- GUDID distribution status
- In Commercial Distribution
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