Radiology AI Directory

FDA-cleared profile

QUANTRA

HOLOGIC, INC.

Authorized purpose: Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.

Breast imagingQuantification and segmentation
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: Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.

Evidence takeaway

Evidence from the reviewed source record: K142037 reports bench measurement, reproducibility, and multivendor agreement validation for Quantra 2.1.

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
Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.
  • 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
Radiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication names radiologists and does not establish the current technologist role.

Care setting and population
Breast-imaging departments performing supported digital mammography or tomosynthesis workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Breast image acquisition, reconstruction, density assessment, or computer-aided interpretation support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Images acquired using digital breast x-ray systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This replaces the current DBT-inclusive input wording with the exact indication text.

Output and human action
Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra also provides area breast density as a ratio of fibroglandular tissue area and total breast area estimates. Quantra segregates breast density into categories.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication directly states the density measures and categories; it does not establish the current reconstructed-image, marks, or scores list.

Limitations
Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication states this limitation and does not state the current compatibility-validation or local-reporting-policy language.

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
K142037
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication states digital breast x-ray systems and does not state DBT. Controlled directory display reconciled from exact FDA wording: Images acquired using digital breast x-ray systems. -> Mammography/DBT.

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
2014-10-10
  • 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
Validate supported acquisition systems, image type and processing, DICOM transfer, hanging protocols, display requirements, result presentation, and archive retention.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Acquisition-system software or networked analysis software on the cleared platform and version.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified breast-imaging technologists and interpreting physicians. should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: Density output is adjunctive and is not an interpretive or diagnostic result; validate acquisition-vendor compatibility and local reporting policy.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K142037 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Validate supported acquisition systems, image type and processing, DICOM transfer, hanging protocols, display requirements, result presentation, and archive retention.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Density output is adjunctive and is not an interpretive or diagnostic result; validate acquisition-vendor compatibility and local reporting policy.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: Density output is adjunctive and is not an interpretive or diagnostic result; validate acquisition-vendor compatibility and local reporting policy.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

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
K142037 reports bench measurement, reproducibility, and multivendor agreement validation for Quantra 2.1.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

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

K142037 FDA performance package for QUANTRA

  • DesignManufacturer measurement, reproducibility, and multivendor agreement validation
  • PopulationSupported digital mammography examinations
  • Scopeexact submission
  • Tested versionQuantra version 2.1
  • IndependenceSponsor or vendor study

K142037

Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

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 FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K142037 by exact submission identifier. This does not exclude product-family or later safety information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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
27Fields reviewed
12Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. 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 20 PubMed and 10 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, acr ai central product, fda decision material, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, 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 K142037: QUANTRA

    U.S. Food and Drug Administration - Published 2014-10-10 - Accessed 2026-09-19

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. QUANTRA model card (K142037)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

  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. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Hologic Quantra breast density assessment

    Hologic - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

Research history

  1. K142037 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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