FDA-cleared profile

MammoScreen BD

Therapixel

Authorized purpose: Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening mammography; it is not diagnostic.

Breast imaging

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

Overview status: Source-reviewed overview

What does this software do? Authorized purpose: Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening mammography; it is not diagnostic.
Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: A DICOM image folder from compatible full-field digital mammography or digital breast tomosynthesis systems, including RCC, LCC, RMLO, and LMLO views; the comparison describes FFDM and 2D synthetic mammography from DBT.
Who uses it? Intended users: Interpreting physicians.
What does the software produce? Output: A four-category ACR BI-RADS 5th Edition breast-density result for each examination, delivered as JSON and capable of presentation through a compatible web UI, PACS viewer using DICOM Structured Report or Secondary Capture, patient worklists, or reporting software.
What is its most important limitation? Key limitation: The output is complementary information, not diagnostic software, and patient-management decisions must not be based solely on it. The primary validation data were Hologic examinations from two U.S. screening centers and one French center. Very small subgroup results, including the eight-patient American Indian, Alaska Native, Native Hawaiian, or Pacific Islander group, have wide uncertainty.

Clinical takeaway

Clinical role: Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening mammography; it is not diagnostic.

Evidence takeaway

Evidence from the reviewed source record: FDA standalone validation used 922 women and 4,274 examinations/images across two U.S. screening centers and one French center, with four views per examination and consensus ground truth from five breast radiologists. Quadratically weighted Cohen kappa was reported as 89.03 (95% CI 87.43-90.56) for the four-class task and 84.50 (95% CI 81.46-87.36) for the dense-versus-non-dense binary task. FFDM-only and 2DSM-only kappa values were 89.11 and 88.89; subgroup kappa values included 87.93, 91.22, and 87.15 by age and 53.85 (95% CI 0.00-83.33) for the eight-patient smallest race group.

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: Adjunctively assess breast tissue composition and provide an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening mammography; it is not diagnostic.

Intended users: Interpreting physicians.

Care setting and population: Screening mammography workflow for asymptomatic women aged 40 years or older; the FDA packet does not specify a facility type.

Workflow role: Concurrent adjunct to physician mammography interpretation, producing breast-density classification for review and reporting through compatible mammography software, PACS, worklists, or reporting systems.

Required input: A DICOM image folder from compatible full-field digital mammography or digital breast tomosynthesis systems, including RCC, LCC, RMLO, and LMLO views; the comparison describes FFDM and 2D synthetic mammography from DBT.

Output and human action: A four-category ACR BI-RADS 5th Edition breast-density result for each examination, delivered as JSON and capable of presentation through a compatible web UI, PACS viewer using DICOM Structured Report or Secondary Capture, patient worklists, or reporting software.

Limitations: The output is complementary information, not diagnostic software, and patient-management decisions must not be based solely on it. The primary validation data were Hologic examinations from two U.S. screening centers and one French center. Very small subgroup results, including the eight-patient American Indian, Alaska Native, Native Hawaiian, or Pacific Islander group, have wide uncertainty.

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: K241561

Modality: Mammography/DBT

Anatomy: Breast

Clearance type: 510(k)

Decision date: 2024-10-02

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

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

Integration: DICOM folder input and JSON output with described integration through MammoScreen Web-UI, compatible PACS via DICOM Structured Report or Secondary Capture, patient worklists, and reporting software; the device is described as virtual-machine software. Specific local interface versions and compatibility are not established.

Deployment and data flow: On-premise

Security and privacy: Vendor documentation pending

Training and support: Vendor documentation pending

Monitoring and change control: Vendor documentation pending

ACR exact-submission catalog context

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

exact submission · checked 2026-09-08

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 standalone validation used 922 women and 4,274 examinations/images across two U.S. screening centers and one French center, with four views per examination and consensus ground truth from five breast radiologists. Quadratically weighted Cohen kappa was reported as 89.03 (95% CI 87.43-90.56) for the four-class task and 84.50 (95% CI 81.46-87.36) for the dense-versus-non-dense binary task. FFDM-only and 2DSM-only kappa values were 89.11 and 88.89; subgroup kappa values included 87.93, 91.22, and 87.15 by age and 53.85 (95% CI 0.00-83.33) for the eight-patient smallest race group.

Reported sensitivity: Research pending

Reported specificity: Research pending

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

MammoScreen BD regulatory performance study summary

DesignStand-Alone Performance
PopulationAdult
Scopeexact submission
Tested versionExact product version not reported; regulatory study summarized for FDA submission K241561
Samplen=922
IndependenceIndependence not established

K241561

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

Reimbursement and coding: Not established in reviewed sources

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 K241561. 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.

Buyer worksheet

Open questions to take to the vendor

Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
Verify pricing and total cost: No public price or quote for the exact K241561 configuration was established in this review.
Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

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

22Fields reviewed

9Source classes checked

0Screened PubMed leads

0Screened trial leads

0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. 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, 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

FDA K241561: MammoScreen BD

U.S. Food and Drug Administration - Published 2024-10-02 - Accessed 2026-09-08

Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
Artificial Intelligence-Enabled Medical Devices

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

Scope: regulatoryIdentity, modalityContext
MammoScreen BD model card (K241561)

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

Scope: intendedUsers, careSetting, output, evidenceSummary, anatomy, evidenceStudies
PubMed biomedical literature index

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

Scope: evidenceDiscovery
ClinicalTrials.gov study registry

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

Scope: evidenceDiscovery, studyStatus
openFDA Device Recall API

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

Scope: recallDiscovery, nativeSubmissionMatching
openFDA exact recall query for K241561

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

Scope: postmarketSafety

Research history

2024-10-02

K241561 FDA decision

Regulatory record

510(k)
2026-09-20

Source-review record updated

Research record

fda record reviewed
2026-09-20

Reader overview source-reviewed

Editorial review

Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K260714

MammoScreen® (5)

Therapixel

Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-06-26

Breast imaging

FDA-cleared K253825

Saige-Dx

DeepHealth, Inc.

Concurrent detection and characterization support for screening DBT mammography

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-06-15

Breast imaging Detection and CADe

FDA-cleared K252954

MammoSightAI

Neurocareai, Inc. (Dba Savelife.Ai)

Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-05-04

Breast imaging Acute triage and notification

FDA-cleared K260320

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-04-23