Provides volumetric breast density, BI-RADS fourth- or fifth-edition density categories and dose/pressure quality metrics from raw mammography or DBT data as adjunctive information for an MQSA-qualified physician's breast-composition assessment.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Provides volumetric breast density, BI-RADS fourth- or fifth-edition density categories and dose/pressure quality metrics from raw mammography or DBT data as adjunctive information for an MQSA-qualified physician's breast-composition assessment.
FDA source Exact FDA submission Checked 2026-09-05
Raw For Processing digital mammograms or raw DBT projections, typically left/right CC and MLO views; compatible sources include images obtained with curved paddles. Version 3.2 adds Giotto Class 2D processing and improved Hologic tomosynthesis support.
FDA source Exact FDA submission Checked 2026-09-05
Fibroglandular and total breast volumes, percentage volumetric breast density, BI-RADS fourth- or fifth-edition density category, average/maximum dense-tissue thickness, maximum dense volume over a square-centimeter region, density maps and quality metrics including dose/pressure; DICOM Secondary Capture scorecard and Mammography CAD Structured Report.
FDA source Exact FDA submission Checked 2026-09-05
Not a diagnostic aid; use only as adjunctive information to the MQSA-qualified physician's final density assessment. Compatible raw data and the accepted manufacturer/configuration list are required.
FDA source Exact FDA submission Checked 2026-09-05
The baseline ACR shorthand Scanner manufacturers: All is narrowed to the FDA summary's supported input configurations; universal scanner support is not inferred.
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
K211279
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
Receives raw mammography/DBT data and generates a DICOM Secondary Capture scorecard, density maps and a DICOM Mammography CAD Structured Report; DICOM 2016 testing is described.
FDA source Exact FDA submission Checked 2026-09-05
The exact summary describes a Microsoft Azure-connected off-the-shelf virtual appliance and lists Windows/Linux operating environments.
FDA source Exact FDA submission Checked 2026-09-05
Refines the baseline On-premise label. The summary does not fully resolve hosting region, what crosses the Azure connection or current commercial topology.
Vendor confirmation Exact product version Checked 2026-09-05
The summary's description of a secure virtual host does not establish a current scoped security attestation or Azure data flow and retention controls.
Training and support
Vendor documentation pending
Vendor confirmation Exact product version Checked 2026-09-05
The physician qualification is known; a version 3.2 training syllabus, duration and competency process were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact product version Checked 2026-09-05
Density sanity checking is described for 3.2, but a site monitoring service or update acceptance program was not established. Editorial questions: confirm raw-image routing, supported paddles and correct scorecard/patient matching.
Current Scorecard family context
The official Scorecard page combines density and risk information and states that Tyrer-Cuzick 8 risk modeling requires additional software purchase and is not available in all countries.
product family · checked 2026-09-05
Does not add risk modeling to the cleared indications of Volpara Imaging Software 3.2.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
Software verification/regression evidence supports the 3.2 modification; the reviewed epidemiology publication is contextual use of the product family.
Reviewed sources checked Exact FDA submission Checked 2026-09-05
The exact summary does not report disease-detection sensitivity; the family epidemiology study is not a software accuracy validation.
Reported specificity
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-05
No disease-detection specificity for version 3.2 was established.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Volpara Imaging Software 3.2 Special 510(k) verification and validation
Software unit and integration validation with repeated predicate tests for compatibility and software modifications. · Software verification dataset; clinical cohort size not reported in the summary.
exact submission · Tested version: Volpara Imaging Software 3.2 · Independence not established
Cadmium and volumetric mammographic density: A cross-sectional study in Polish women
Cross-sectional epidemiology study relating urinary cadmium to volumetric mammographic density. · 517 women aged 40-60 undergoing screening mammography in Lodz, Poland; raw CC and MLO images analyzed with Volpara.
product family · Tested version: Volpara Imaging Software; version not specified in reviewed abstract · n=517 · Independence not established
PMID:32433664 · DOI:10.1371/journal.pone.0233369
Abstract reviewed. This is use of a measurement tool, not a sensitivity/specificity study or validation of version 3.2. No software-outcome claim is extracted.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Research pending
Needs research Exact product version Checked 2026-09-05
No priced contract or exact version 3.2 quote was reviewed. The Scorecard product page indicates additional purchase for risk modeling but does not establish a price for this cleared configuration.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-05
Applicable payer policy content was not reviewed; a density-reporting requirement is not a software payment determination.
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
Verify security and privacy controls: The summary's description of a secure virtual host does not establish a current scoped security attestation or Azure data flow and retention controls.
Verify training: The physician qualification is known; a version 3.2 training syllabus, duration and competency process were not established.
Verify pricing and total cost: No priced contract or exact version 3.2 quote was reviewed. The Scorecard product page indicates additional purchase for risk modeling but does not establish a price for this cleared configuration.
Verify reimbursement and coding relevance: Applicable payer policy content was not reviewed; a density-reporting requirement is not a software payment determination.
Verify local validation and lifecycle monitoring: Density sanity checking is described for 3.2, but a site monitoring service or update acceptance program was not established. Editorial questions: confirm raw-image routing, supported paddles and correct scorecard/patient matching.
Verify recalls and postmarket safety signals: 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.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
19Fields reviewed
10Source classes checked
3Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored titles screened: 35913368 (ionizing radiation) and 34524273 (cigarette smoking) are density epidemiology leads without exact-version linkage in metadata; not promoted. PMID 32433664 abstract reviewed live and retained only as contextual product-family use. No trials stored. The current discovery snapshot contains 3 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, peer reviewed publication, literature index, trial registry, pubmed, clinical trials, openfda device recall
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