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 2026-09-06FDA-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.
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
- 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.
- Intended users
- Physicians interpreting mammograms, including radiologists
- Care setting and population
- Adult screening mammography; asymptomatic women aged 40 years or older
- Workflow role
- Breast-density assessment support
- 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.
- 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.
- Limitations
- Adjunctive information only; not diagnostic, and patient-management decisions should not be made solely from MammoScreen BD.
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.
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.
- Deployment and data flow
- On-premise
Baseline deployment category preserved; the reviewed sources do not establish current hosting region, retention, or commercial configuration.
- Security and privacy
- Vendor documentation pending
No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
- Training and support
- Vendor documentation pending
Current onboarding, competency, and support commitments were not established.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, update control, and drift review were not established.
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 2026-09-07Family-level commercial model only; it is not treated as a price for the K243685 configuration.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- 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.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
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
Standalone clinical validation against consensus reference · Asymptomatic women aged 40 years or older undergoing screening mammography on compatible FFDM and DBT systems
exact submission · Tested version: MammoScreen BD submitted in K243685; build not stated · Independence not establishedK243685
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.
Economics and lifecycle
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.
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
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
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: No scoped current security, data-flow, access-control, retention, or incident-response documentation was established.
- Verify training: Current onboarding, competency, and support commitments were not established.
- Verify reimbursement and coding relevance: No payer or CMS policy review was performed in this worker cohort.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, update control, and drift review were not established.
- 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.
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
0Reviewed PubMed leads
0Reviewed 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
Source ledger
Sources accessed through 2026-09-07.
- FDA 510(k) K243685: MammoScreen BD U.S. Food and Drug Administration · 2026-09-06
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- MammoScreen BD model card (K243685) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- MammoScreen official product page Therapixel · 2026-09-07
- MammoScreen official FAQ Therapixel · 2026-09-07
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
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
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
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