CogNet AI-MT+
510(k) K252482
CogNet AI-MT+ is a medical device (FDA Class II; FDA product code QFM, Radiological Computer-Assisted Prioritization Software For Lesions) made by Medcognetics, Inc., cleared under FDA 510(k) K252482 on 11 Dec 2025, 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 | FDA 510(k)SESE | NumberK252482 | Date11 Dec 2025 | StatusActive |
Official records
- FDA 510(k) database K252482
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QFM
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K252482
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cognet AI MT+ | MT+ | 00860007434716 | — | On the market |
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