510(k) · Cleared
ClearedCogNet AI-MT+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcognetics, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Dec 11, 2025 as substantially equivalent to K220080 (Medcognetics, Inc., 2022) after a 126-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Dec 11, 2025
- Review
- 126 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK200905 HealthMammoZebra Medical Vision, Ltd. · 2020
- 1 generation backK220080 CogNet QmTRIAGEMedcognetics, Inc. · 2022
- This deviceK252482 CogNet AI-MT+Medcognetics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220080 | CogNet QmTRIAGESummary page 5…and notification software Regulatory Class: II Product Code: QFM III. PREDICATE DEVICE CogNet QmTRIAGE (Renamed to CogNet AI-MT), K220080 This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The MedCognetics Cog… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K220080.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (175 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252482: CogNet AI-MT+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252482
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026