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Last updated: June 10, 2026
Back to directoryClairity Breast medical AI product profile
AI mammography risk-prediction platform, authorized as Allix5, that estimates five-year future breast cancer risk from compatible 2D screening mammograms.
Medical imaging and radiology
Best fit
Screening programs that want image-based risk stratification for prevention and enhanced-screening discussions while keeping mammogram interpretation and care recommendations clinician-led.
- Primary use case
- FDA-authorized AI risk prediction from bilateral screening mammograms to estimate five-year future breast cancer risk after radiologist interpretation
- Audience
- Breast imaging centers, women's health programs, radiology groups, cancer prevention clinics, and health-system screening leaders
- Risk level
- High
- Pricing signal
- Public pages do not list contract pricing; verify launch state, health-system availability, payer coverage, implementation, DICOM/HL7 integration, support, privacy, and prescription-use terms.
- Official sources
- 6 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Clairity Breast as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as prescription-use Class II radiological software for future risk prediction, not detection or diagnosis; match local use to DEN240047 labeling, compatible mammography systems, output timing, and post-market obligations. |
|---|---|
| Privacy | Review mammography image routing, DICOM metadata, HL7 return path, cloud or on-prem processing, access controls, retention, support access, BAA terms, cybersecurity documentation, audit logs, and model-change governance. |
| Evidence | Use the FDA decision summary and vendor validation claims as starting points, then validate calibration, discrimination, subgroup performance, implant limitations, high-score overestimation, and downstream screening changes in the local population. |
| Workflow | Best governed as radiologist- and clinician-reviewed risk stratification after screening interpretation, with explicit counseling scripts, enhanced-screening criteria, threshold review, equity monitoring, and exception handling. |
Where Clairity Breast fits
Clairity describes Clairity Breast as an FDA-authorized AI platform that predicts five-year future breast cancer risk from an existing screening mammogram. FDA's De Novo record identifies Allix5 as a Class II radiological software device to predict future breast cancer risk, granted under DEN240047 on 2025-05-30; the FDA summary states it is not intended to diagnose, detect, guide imaging interpretation, or provide care recommendations, and it is limited to directly acquired 2D images from specified Hologic systems.
Not for: Breast cancer detection, diagnosis, treatment recommendation, autonomous screening decisions, unsupported mammography systems, synthetic 2D images, known-cancer presentations, or deployments without radiologist-completed interpretation and clinician counseling.
What to verify before using Clairity Breast
- Whether the deployed product is Clairity Breast/Allix5 under De Novo DEN240047 and the exact intended-use, prescription-use, labeling, warning, and contraindication language.
- Compatible input scope: bilateral screening mammograms, directly acquired 2D images, Hologic Lorad Selenia or Selenia Dimensions systems, no synthetic 2D images, and eligible patients without known breast cancer at screening.
- How DICOM images move from PACS, how Allix5 returns output through HL7, where the score appears in clinical systems, and whether clinicians see output only after the radiologist completes screening interpretation.
- Privacy, BAA, data-processing, retention, support access, audit logs, cybersecurity materials, model update controls, post-market monitoring, adverse event workflow, and whether local data are used for model improvement.
- Local validation by age, race, ethnicity, breast density, implant status, scanner mix, calibration, high-risk thresholds, false reassurance, overestimation above 5 percent risk, MRI or contrast-enhanced follow-up rates, and patient counseling burden.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- clairity.com
- clairity.com / patients
- clairity.com / healthcare-providers
- clairity.com / about
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / reviews
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