510(k) · Cleared
ClearedCogNet QmTRIAGE
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 Sep 29, 2022 as substantially equivalent to K200905 (Zebra Medical Vision, Ltd., 2020) after a 262-day review. Its family tree reaches back 3 generations to 2018. 2 later devices descend from it.
- Decided
- Sep 29, 2022
- Review
- 262 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK200905 HealthMammoZebra Medical Vision, Ltd. · 2020
- This deviceK220080 CogNet QmTRIAGEMedcognetics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252482 CogNet AI-MT+Medcognetics, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233108 VinDr-MammoVinbigdata Joint Stock Company · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K200905 | HealthMammo | Zebra Medical Vision, Ltd. | 2020 | — |
| 0 (this device) | K220080 | CogNet QmTRIAGE | Medcognetics, Inc. | 2022 | — |
| +1 | K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 2025 | — |
| +1 | K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K200905 | HealthMammoSummary page 4…e: Radiological computer aided triage and notification software Product Code: QFM Class 2 Regulation Number 892.2080 c) Predicate Devices: K200905 Zebra Medical Vision Ltd. HealthMammo Cleared July 16, 2020 d) Device Description: The MedCognetics (CogNet)… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K252482 (Medcognetics, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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) QmTRIAGE TM software is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. QmTRIAGETM utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence ofat least one suspicious finding at the exam…
Read the full statement (174 words)
The MedCognetics (CogNet) QmTRIAGE TM software is a passive notification for prioritization-only, parallel-workflow
software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings in the
medical care environment. QmTRIAGETM utilizes an artificial intelligence algorithm to analyze 2D FFDM screening
mammograms and flags those that are suggestive of the presence ofat least one suspicious finding at the exam level.
QmTRIAGE TM 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 QmTRIAGETm 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 QmTRIAGETM device is intended for use with complete 2D FFDM mammography exams acquired using validated
FFDM systems only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220080: CogNet QmTRIAGE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220080
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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