CogNet QmTRIAGE
K220080MedCognetics, Inc. · cleared 2022-09-29 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The MedCognetics (CogNet) QmTRIAGE is a non-invasive computer-assisted triage and notification software as a medical device (SaMD) that analyzes 2D FFDM screening mammograms using a machine learning algorithm and notifies a PACS/workstation of the presence of findings suspicious of cancer in a study.”
source quote (p.3)
“QmTRIAGE utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level.”
Validation studies (1)
Retrospective clinical
n=800 cases
endpoints: triage of 2D FFDM in mammogram cases
Reported performance (3 observations)
source quote (p.6)
“Also validated was Sensitivity and Specificity, achieving an overall Sensitivity of 87% and a Specificity of 89% across the entire test dataset, without subgroup breakdown, which exceeded the standard of care as reported in the Breast Cancer Surveillance Consortium (BCSC) study.”
source quote (p.6)
“Also validated was Sensitivity and Specificity, achieving an overall Sensitivity of 87% and a Specificity of 89% across the entire test dataset, without subgroup breakdown, which exceeded the standard of care as reported in the Breast Cancer Surveillance Consortium (BCSC) study.”
source quote (p.6)
“The validation of the performance of MedCognetics' QmTRIAGE algorithm for triage of 2D FFDM achieved an overall Area Under Receiver Operating Characteristics (AUROC) of 0.9569 with 95% CI: 0.9364-0.9738 across the entire test dataset, without subgroup breakdown.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252482 (decision 2025-12-11) from Medcognetics, Inc. for a matching device line ("CogNet AI-MT+") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252482
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).