Supported acquisition environment
Supported hardware: Unspecified. Scanner manufacturers: GE;Hologic/Lorad
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
MammoScreen 2.0
Therapixel
Authorized purpose: Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
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: Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
- Which images or clinical context are in scope? Modality: Mammography/DBT Anatomy or clinical context: Breast Input: Four standard screening views, one CC and one MLO per breast, from FFDM or DBT.
- Who uses it? Intended users: Physicians qualified to read screening mammograms
- What does the software produce? Output: Finding marks and level-of-suspicion scores for soft-tissue lesions or calcifications at finding, breast, and exam levels.
- What is its most important limitation? Key limitation: Concurrent aid, not a replacement for physician review or judgment; management decisions must not rely solely on it.
Clinical takeaway
Clinical role: Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
Evidence takeaway
Evidence from the reviewed source record: FDA reports two MRMC crossover studies, one FFDM and one DBT, on 240 enriched cases; FFDM AUC was 0.79 standalone and 0.80 aided, and DBT AUC was 0.84 standalone and 0.83 aided.
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
- Concurrent reading aid for interpreting physicians reading screening FFDM or DBT, to identify findings and assess suspicion; it is not the sole basis for management.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Physicians qualified to read screening mammograms
FDA intended-user statement.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Four standard screening views, one CC and one MLO per breast, from FFDM or DBT.
FDA device description.
- Output and human action
- Finding marks and level-of-suspicion scores for soft-tissue lesions or calcifications at finding, breast, and exam levels.
FDA indication and device-description output wording.
- Limitations
- Concurrent aid, not a replacement for physician review or judgment; management decisions must not rely solely on it.
FDA warnings and predicate-comparison boundary.
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
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for MammoScreen 2.0; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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 reports two MRMC crossover studies, one FFDM and one DBT, on 240 enriched cases; FFDM AUC was 0.79 standalone and 0.80 aided, and DBT AUC was 0.84 standalone and 0.83 aided.
Submission-reported reader-study summary; not an independent validation.
- Reported sensitivity
- 82%
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 90%
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
MammoScreen® regulatory performance study summary
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested version2
- Samplen=27500
- Sites4
- IndependenceIndependence not established
K211541
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K211541 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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 K211541. 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 K211541 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.
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
27Fields reviewed
10Source 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, fda decision summary packet, 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 K211541: MammoScreen 2.0
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
MammoScreen® model card (K211541)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K211541
Scope: postmarketSafety
Research history
-
K211541 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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