Radiology AI Directory

FDA-cleared profile

CogNet AI-MT+

Medcognetics, Inc.

Authorized purpose: Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.

Breast imagingAcute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.

Evidence takeaway

Evidence from the reviewed source record: The FDA summary reports a standalone retrospective diagnostic-enriched DBT study; no general-population screening performance claim is made.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
MQSA interpreting physicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states that the software tool is for MQSA interpreting physicians reading mammograms.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Four bilateral DICOM For Presentation DBT views from Hologic Selenia Dimensions; validation excluded breast implants and post-surgical studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
DICOM Secondary Capture and private DICOM tags with Suspicious/red-diamond or Processed/blue-circle status; no diagnostic viewer is supplied.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
Passive triage only, not diagnostic information; output cannot remove images or replace MQSA physician review and is limited to validated Hologic Dimensions DBT input.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K252482
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Breast
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-12-11
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Input may be routed from PACS, modality or a DICOM router; output may populate an API worklist column.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Cloud-based licensed access is described in the summary.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact product version
  • Checked 2026-09-05

Technical controls in the summary do not establish a current formal security attestation.

Training and support
Licensed users receive a user manual and quality/technical staff provide initial usage support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Current family scope note

The vendor's embedded AI material is labeled investigational and is not treated as a cleared deployment capability for CogNet AI-MT+.

product family · checked 2026-09-05
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The FDA summary reports a standalone retrospective diagnostic-enriched DBT study; no general-population screening performance claim is made.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
88.09
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Standalone retrospective endpoint; study context applies.

Reported specificity
91.56
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Standalone retrospective endpoint; study context applies.

Sensitivity

0.8809 proportion

  • EndpointStandalone suspicious-exam triage classification
  • Population806 women; 403 biopsy-proven malignancy and 403 benign/negative reference cases
  • Tested versionCogNet AI-MT+
Source

Specificity

0.9156 proportion

  • EndpointStandalone suspicious-exam triage classification
  • Population806 women; 403 biopsy-proven malignancy and 403 benign/negative reference cases
  • Tested versionCogNet AI-MT+
Source

CogNet AI-MT+ regulatory standalone DBT evaluation

  • DesignRetrospective standalone diagnostic-enriched evaluation.
  • Population806 women using Hologic Selenia Dimensions DBT; 50% cancer-enriched.
  • Scopeexact submission
  • Tested versionCogNet AI-MT+
  • Samplen=806
  • IndependenceIndependence not established

K252482

Not representative of screening prevalence.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact product version
  • Checked 2026-09-06
Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-06

No applicable payer policy reviewed.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-19Last searched
27Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored literature or trial candidates; empty metadata snapshots were screened. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K252482: CogNet AI-MT+

    U.S. Food and Drug Administration - Published 2025-12-11 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, input, output, limitations, intendedUsers, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. CogNet AI-MT+ model card (K252482)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. CogNet AI-MT+: K252482 clearance and 510(k) summary

    US Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, implementation, evidence

  8. MedCognetics embedded AI

    MedCognetics - Accessed 2026-09-05

    Scope: product_family_scope_limit

Research history

  1. K252482 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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