Cognet AI MT
Cognet AI MT is a X-ray image interpretive software (FDA Class II; FDA product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions) made by Medcognetics, Inc, cleared under FDA 510(k) K220080 on 29 Sep 2022 and listed in FDA GUDID since 11 Sep 2023 (UDI-DI 00860007434709), 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 | Number00860007434709 | Date11 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220080 | Date29 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 00860007434709
- FDA 510(k) database K220080
Across registries
- FDA 510(k) K220080 decided 29 Sep 2022 Active
- FDA GUDID UDI-DI 00860007434709 listed 11 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K220080
- Listed FDA GUDID 00860007434709
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cognet AI
- Generic name
- X-ray image interpretive software
- Model / reference
- MT
- Primary DI / UDI-DI
- 00860007434709
- 510(k) Number
- FDA product code
- QFM
- 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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