Family integration
DICOM Secondary Capture and Structured Report output; optional HL7/FHIR reporting integration.
product family · checked 2026-09-06FDA-cleared profile
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.
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
- Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
- Intended users
- Physicians interpreting screening mammograms.
- Care setting and population
- Screening mammography workflow.
- Workflow role
- Concurrent reading/reporting aid; includes an initial report populated with selected findings.
- Required input
- Compatible GE or Hologic FFDM or DBT screening exams, with optional priors; supplementary XCCM, XCCL and ML views are supported in specified scenarios.
- Output and human action
- Finding-, breast- and case-level scores from 1 to 10, locations and finding marks for masses, asymmetries, distortions and calcifications.
- Limitations
- Not a standalone diagnostic device and not a substitute for physician review; the MammoScreen 5 algorithm is unchanged from MammoScreen 4.
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
- Current MammoScreen family documentation describes a site virtual gateway, DICOM Secondary Capture and Structured Report output, and optional EMR/reporting API integration using HL7/FHIR.
Current family documentation, not evidence that every interface or package shipped with the cleared version.
- Deployment and data flow
- Current family documentation describes a site gateway with cloud computation and an on-premises option available on request.
- Security and privacy
- Vendor documentation pending
Current integration marketing was reviewed but no scoped, dated security attestation was established.
- Training and support
- The vendor offers a limited-time pilot with remote installation and training.
Duration, curriculum and applicability to version 5 are not stated.
- Monitoring and change control
- Vendor documentation pending
No site monitoring or update-acceptance procedure was established.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Regulatory performance evidence is from the prior MammoScreen 3 clinical dataset, not a new MammoScreen 5 clinical study.
- Reported sensitivity
- Not established in reviewed sources
No version-5 sensitivity value with complete endpoint context was abstracted.
- Reported specificity
- Not established in reviewed sources
No version-5 specificity value with complete endpoint context was abstracted.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
MammoScreen 3 regulatory standalone performance dataset
Retrospective standalone regulatory dataset. · 9,789 screening studies with biopsy-positive, benign-with-follow-up or negative-follow-up reference classification.
product family · Tested version: MammoScreen 3 data cited by MammoScreen 5 summary · n=9789 · Independence not establishedK260714
The submission reports the algorithm unchanged from MammoScreen 4 and no new clinical study; this is not represented as a new version-5 trial.
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
- Not established in reviewed sources
No public price or contract for MammoScreen 5 was located in the reviewed vendor material.
- Reimbursement and coding
- Research pending
No applicable payer policy was reviewed.
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: Current integration marketing was reviewed but no scoped, dated security attestation was established.
- Verify pricing and total cost: No public price or contract for MammoScreen 5 was located in the reviewed vendor material.
- Verify reimbursement and coding relevance: No applicable payer policy was reviewed.
- Verify local validation and lifecycle monitoring: No site monitoring or update-acceptance procedure was 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
2026-09-06Last searched
19Fields reviewed
10Source classes checked
1Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored PMID 32159424 is an online breast-cancer risk decision-aid study, not MammoScreen product evidence; excluded by metadata. No trial records stored. The current discovery snapshot contains 1 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, acr ai central product, fda decision summary, vendor product page, vendor technical page, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-06.
- K260714 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- MammoScreen® (5) model card (K260714) 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 5: K260714 clearance and 510(k) summary US Food and Drug Administration · 2026-09-05
- MammoScreen integration Therapixel / MammoScreen · 2026-09-06
- Try MammoScreen Therapixel / MammoScreen · 2026-09-06
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