Radiology AI Directory

FDA-cleared profile

MammoScreen BD

Therapixel

MammoScreen BD evaluates 2D mammography standard views (CC and/or MLO) from compatible FFDM and/or 2D synthetic mammography from DBT to assign an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening; it is adjunctive, not diagnostic, and patient management remains with the interpreting physician.

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.

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
MammoScreen BD evaluates 2D mammography standard views (CC and/or MLO) from compatible FFDM and/or 2D synthetic mammography from DBT to assign an ACR BI-RADS 5th Edition breast-density category for asymptomatic women aged 40 years or older undergoing screening; it is adjunctive, not diagnostic, and patient management remains with the interpreting physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Physicians interpreting mammograms, including radiologists
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Adult screening mammography; asymptomatic women aged 40 years or older
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Breast-density assessment support
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
DICOM 2D mammography standard views (CC and/or MLO) from compatible FFDM and/or DBT systems using 2D synthetic mammography; the FDA labeling describes Hologic and GE compatible systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
A breast-density category of A, B, C, or D; output is provided as JSON and can be displayed as a DICOM Structured Report, DICOM Secondary Capture Image, or in patient worklists through compatible third-party software.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
Adjunctive information only; not diagnostic, and patient-management decisions should not be made solely from MammoScreen BD.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

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
K243685
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Mammography/DBT
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Anatomy
Breast
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-08-22
  • 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 submission describes DICOM input and JSON output, with optional DICOM SR, DICOM Secondary Capture, and worklist display through third-party software; local interface compatibility remains site-specific.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-09-06

Baseline deployment category preserved; the reviewed sources do not establish current hosting region, retention, or commercial configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Current onboarding, competency, and support commitments were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Local acceptance testing, production monitoring, update control, and drift review were not established.

DICOM and JSON result pathways

The exact submission describes DICOM mammography input and JSON output, with optional DICOM Structured Report, Secondary Capture, and compatible worklist display.

exact submission · checked 2026-09-06
Source

Family pricing model

MammoScreen's official FAQ describes SaaS pricing on a pay-per-successfully-processed-mammogram basis; no amount or contract term is published.

product family · checked 2026-09-07

Family-level commercial model only; it is not treated as a price for the K243685 configuration.

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
Standalone clinical validation compared MammoScreen BD density categories with consensus from five breast radiologists; the FDA packet describes validation across compatible FFDM and DBT inputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

MammoScreen BD breast-density clinical validation

  • DesignStandalone clinical validation against consensus reference
  • PopulationAsymptomatic women aged 40 years or older undergoing screening mammography on compatible FFDM and DBT systems
  • Scopeexact submission
  • Tested versionMammoScreen BD submitted in K243685; build not stated
  • IndependenceIndependence not established

K243685

Reference standard was the consensus of five breast radiologists; exact enrollment count was not used here because it was not consistently exposed in the extracted packet text.

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
MammoScreen family SaaS priced per successfully processed mammogram; the official FAQ also states that version updates are automatic.
  • Vendor supplied
  • Product family
  • Checked 2026-09-07

The reviewed FAQ does not publish an exact amount, currency, geography, or contract term. Cloud de-identification/deletion statements were not treated as a scoped security audit.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

No payer or CMS policy review was performed in this worker cohort.

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

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
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

No stored PubMed or ClinicalTrials.gov candidate identifiers for this submission in the 2026-09-01 snapshot; exact-submission recall candidate review was also zero. This metadata screen is not a full paper review. 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, vendor product page, vendor faq, literature index, trial registry, 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) K243685: MammoScreen BD

    U.S. Food and Drug Administration - Published 2025-08-22 - Accessed 2026-09-06

    Scope: identity, purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, deployment, evidenceSummary, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. MammoScreen BD model card (K243685)

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

    Scope: intendedUsers, careSetting, output, 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. MammoScreen official product page

    Therapixel - Accessed 2026-09-07

    Scope: productFamilyWorkflow, implementationCapabilities

  8. MammoScreen official FAQ

    Therapixel - Accessed 2026-09-07

    Scope: pricingModel, implementationCapabilities

Research history

  1. K243685 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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