Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryMammoScreen medical AI product profile
Therapixel breast-screening AI for 2D and 3D mammography that supports radiologist-reviewed suspicious-lesion scoring and workflow assistance.
Medical imaging and radiology
Best fit
Breast imaging programs comparing FDA-cleared and CE-marked mammography AI for detection support, priors, pre-check, and reporting workflow.
- Primary use case
- AI-assisted mammography reading, suspicious-lesion scoring, pre-check workflow, priors-informed review, and breast-density support
- Audience
- Breast imaging centers, radiology groups, screening programs, and health systems evaluating mammography AI
- Risk level
- High
- Pricing signal
- SaaS pricing is described publicly; verify current per-exam pricing, module scope, country availability, and integration terms.
- Official sources
- 5 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 MammoScreen as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match each MammoScreen module and version to its specific FDA, CE, or local authorization because detection, breast density, and workflow assistance should not be treated as one blanket clearance. |
|---|---|
| Privacy | Review mammography image routing, DICOM metadata, SaaS processing, retention, access controls, audit logs, subprocessor terms, and business-associate or data-processing agreements. |
| Evidence | Validate reader-study evidence and local performance for the target modality, density mix, scanner fleet, cancer prevalence, recall patterns, and radiologist interaction model. |
| Workflow | Best governed as radiologist-reviewed breast-screening support with explicit rules for how scores, priors, density output, and draft-report signals influence final interpretation. |
Where MammoScreen fits
MammoScreen describes a 2D and 3D FDA-cleared breast cancer screening AI solution with pre-check, priors, pre-reporting, and scoring workflows; Therapixel and FDA materials list MammoScreen clearances including K192854, K243679, K241561, and K243685 for detection or breast-density software.
Not for: Autonomous screening decisions, unsupported countries or modalities, or assuming detection, density, priors, and workflow features share one intended use.
What to verify before using MammoScreen
- Whether the exact MammoScreen version and module are cleared or available for the intended country, modality, and mammography system.
- FDA 510(k) records such as K192854, K243679, K241561, or K243685 as applicable to detection or breast-density workflow.
- How scores, priors, pre-check output, pre-reporting content, and density output appear in PACS, worklists, reports, and radiologist review.
- Local performance by breast density, scanner vendor, screening population, false positives, false negatives, recall rate, and reading-time impact.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.mammoscreen.com
- www.mammoscreen.com / faq
- www.mammoscreen.com / mammoscreen-fda-cleared-available-for-sale-us
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / scripts / cdrh
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