Radiology AI Directory

FDA-cleared profile

cmTriage

CureMetrix, Inc

Authorized purpose: Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.

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: Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.

Evidence takeaway

Evidence from the reviewed source record: FDA reviewed a retrospective, blinded, multicenter study of 1,255 US mammographic studies (400 biopsy-proven cancers and 855 normal studies with BI-RADS 1/2 and two-year negative follow-up), using up to four standard views per study; the dataset was enriched with cancers. The observed primary sensitivity was 86.9% (95% CI: 83.6%-90.2%) and specificity was 88.5% (95% CI: 86.4%-90.7%). AUC was 0.951 (95% CI: 0.937-0.964) as a separate endpoint. At a separate 84.4% sensitivity operating point, specificity was 94.0% and the population-adjusted mark rate was 6.37%; average timing was 3.35 minutes at 10 Mbit/s upload and 37 Mbit/s download.

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
Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Breast cancer screening and standard-of-care mammography workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Passive notification and exam prioritization in parallel with the standard-of-care worklist; the radiologist decides how to use the code and reviews every exam diagnostically.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM 2D FFDM screening mammograms, with up to four standard views (LCC, LMLO, RCC, and RMLO); the device does not operate for sites using only digital breast tomosynthesis (DBT).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A DICOM Structured Report with a cmTriage code of Suspicious or blank is routed to the PACS worklist, where the exam may be sorted if the PACS supports that function. No diagnostic information beyond triage categorization is provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device is limited to 2D FFDM screening mammograms and cannot be used where only 3D/DBT is acquired. It is prescription-only, passive rather than a proactive alert, does not alter or remove images, and must not replace full patient evaluation or diagnostic viewer review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K183285
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Breast
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2019-03-08
  • 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
A PACS listener/local DICOM router sends a de-identified and encrypted local copy to the CureMetrix cloud; the result DICOM SR returns through cmEdge, is re-associated with the original study, and is routed to the PACS. PACS features vary by manufacturer and a specific local interface is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS is explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for cmTriage; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
FDA reviewed a retrospective, blinded, multicenter study of 1,255 US mammographic studies (400 biopsy-proven cancers and 855 normal studies with BI-RADS 1/2 and two-year negative follow-up), using up to four standard views per study; the dataset was enriched with cancers. The observed primary sensitivity was 86.9% (95% CI: 83.6%-90.2%) and specificity was 88.5% (95% CI: 86.4%-90.7%). AUC was 0.951 (95% CI: 0.937-0.964) as a separate endpoint. At a separate 84.4% sensitivity operating point, specificity was 94.0% and the population-adjusted mark rate was 6.37%; average timing was 3.35 minutes at 10 Mbit/s upload and 37 Mbit/s download.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone exam-level sensitivity at the reported primary operating point: 86.9% (95% CI: 83.6%-90.2%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint for the 1,255-study 2D FFDM evaluation; the 84.4% operating point and AUC are distinct results.

Reported specificity
Standalone exam-level specificity at the reported primary operating point: 88.5% (95% CI: 86.4%-90.7%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint separately from the AUC, mark rate, and timing results.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

cmTriage regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K183285
  • Samplen=1255
  • IndependenceIndependence not established

K183285

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K183285 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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
The exact-identifier FDA recall query returned no native recall record for K183285. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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
2026-09-20Last searched
26Fields reviewed
9Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 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, fda device recall, literature index, trial registry, 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 K183285: cmTriage

    U.S. Food and Drug Administration - Published 2019-03-08 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. cmTriage model card (K183285)

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

    Scope: intendedUsers, output, limitations, 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. openFDA exact recall query for K183285

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

    Scope: postmarketSafety

Research history

  1. K183285 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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