# K252482: CogNet AI-MT+

- Pathway: 510(k) (Traditional)
- Applicant: Medcognetics, Inc.
- Decided: Dec 11, 2025 after 126 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220080: CogNet QmTRIAGE, Medcognetics, Inc. (2022) Summary page 5.

## Indications for use
The MedCognetics CogNet AI-MT+ software is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize viewing patients with suspicious findings in the medical care environment. CogNet AI-MT+ utilizes an artificial intelligence algorithm to analyze DBT screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. CogNet AI-MT+ produces an exam level output to a PACS/Workstation for flagging the suspicious study and allows for worklist prioritization. MQSA qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography, according to the current standard of care. The CogNet AI-MT+ device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician’s worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The CogNet AI-MT+ device is intended for use with DBT mammography exams acquired using validated DBT equipment only.

Source page: https://510kreport.com/device/K252482
Methodology: https://510kreport.com/methodology