Radiology AI Directory

FDA-cleared profile

Quantra

HOLOGIC, INC.

Authorized purpose: Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.

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 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.

Evidence takeaway

Evidence from the reviewed source record: K163623 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Quantra 2.2. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.

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 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Radiologists and qualified breast-imaging professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Mammography and breast-imaging reporting workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Breast-density categorization and adjunct radiologist assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Digital mammographic images from supported digital breast X-ray systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
A breast-density category or result per subject for radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
The FDA labeling describes Quantra as additional information and not a diagnostic aid. Use remains limited to supported digital mammography images and requires radiologist assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

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
K163623
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Breast; mammographic breast-density composition
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2017-10-20
  • 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
The FDA package describes digital mammographic image input and a density result used in the radiologist's reporting workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

The exact FDA decision material does not establish complete deployment topology, hosting responsibility, availability, upgrade, or service boundaries.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact submission 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
Use by radiologists and qualified breast-imaging professionals. Follow the exact labeling, local training, supervision, and escalation requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor labeled population, acquisition quality, exclusions, reviewer overrides, failures, and downstream workflow effects for K163623.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Release and scope verification

Map installed build, options, population, anatomy, inputs, outputs, and enabled functions to K163623.

exact submission · checked 2026-09-04
Source

Deployment boundary

The exact public deployment boundary is incomplete; confirm hosting, data flow, availability, upgrades, security, service, and downtime locally.

exact submission · checked 2026-09-04
Source

Interoperability acceptance

The FDA package describes digital mammographic image input and a density result used in the radiologist's reporting workflow.

exact submission · checked 2026-09-04
Source

Clinical acceptance

Test labeled population, acquisition quality, exclusions, failed inputs, reviewer overrides, and downstream effects for K163623.

exact submission · checked 2026-09-04
Source

Economic evaluation

Exact-product price, implementation cost, reimbursement, and total-cost evidence remain to be obtained; do not infer them from FDA clearance.

product family · checked 2026-09-04
Source

Lifecycle monitoring

Monitor labeling, software version, complaints, recalls, failed inputs, overrides, and postmarket signals against the exact submission and installed configuration.

exact submission · checked 2026-09-04
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
K163623 FDA decision material establishes the labeled use, workflow, inputs, outputs, and limitations for Quantra 2.2. No exact-submission clinical performance metric is promoted without a complete source table and version-scoped endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Do not generalize an endpoint across populations, thresholds, versions, or workflows; use only exact evidence.metrics records.

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

K163623 FDA evidence package for Quantra

  • DesignFDA 510(k) decision evidence and product verification for the exact submission.
  • PopulationBreast; mammographic breast-density composition
  • Scopeexact submission
  • Tested versionQuantra 2.2
  • IndependenceSponsor or vendor study

K163623

FDA-submitted evidence for the exact decision; it is not independent clinical validation and does not establish local production qualification.

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 2026-09-04

No public list price or commercial contract for the exact submission and version was identified.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-product payer coverage or reimbursement determination was identified in reviewed public material.

No product-specific code

No exact-product reimbursement determination identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This public-policy review is not a coverage determination. Verify payer, site-of-service, coding, and local value assumptions independently.

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
No record matched K163623 by exact native submission identifier in the 2026-09-02 openFDA snapshot; this does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

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.

Human reviewedStatus
2026-09-04Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

No evidence was promoted. Breast-density records test Quantra 2.0 or omit a version rather than Quantra 2.2; the other PubMed and trial records concern the unrelated HemoSonics Quantra coagulation product. 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, fda decision summary, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, 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 510(k) decision material K163623: Quantra

    U.S. Food and Drug Administration - Published 2017-10-20 - Accessed 2026-09-04

    Scope: identity, submission_linkage, modality, anatomy, clinical_use, intended_users, care_setting, workflow_role, input, output, limitations, evidence

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Quantra model card (K163623)

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

    Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies

  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

Research history

  1. K163623 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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