Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryScreenPoint Transpara medical AI product profile
Breast AI suite for 2D mammography and digital breast tomosynthesis workflows, including detection and density support.
Medical imaging and radiology
Best fit
Breast screening programs comparing AI second-reader, case-scoring, density, and prior-comparison workflows for radiologist-reviewed mammography.
- Primary use case
- AI-assisted breast cancer detection, density assessment, temporal comparison, and mammography workflow support
- Audience
- Breast imaging centers, screening programs, radiology groups, and health systems evaluating mammography AI
- Risk level
- High
- Pricing signal
- Enterprise breast-imaging pricing; verify current module availability, market access, viewer integration, and service terms.
- Official sources
- 3 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 ScreenPoint Transpara as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact Transpara module, version, country, modality, and 510(k) or CE status because detection, density, and comparison features should not be treated as one blanket authorization. |
|---|---|
| Privacy | Review mammography image routing, DICOM metadata handling, cloud or on-prem deployment, retention, access controls, subprocessors, and business-associate or data-processing terms. |
| Evidence | Check evidence for the target screening population, dense-breast subgroup, 2D versus DBT workflow, cancer subtype, recall impact, and radiologist interaction model. |
| Workflow | Best governed as radiologist-reviewed mammography support with local rules for when AI marks or scores change read order, second-read strategy, recall decisions, and documentation. |
Where ScreenPoint Transpara fits
ScreenPoint describes Transpara as a breast AI suite for detection, density, and temporal-comparison workflows and states that Transpara is CE marked and FDA cleared for 2D and 3D mammography; FDA records list Transpara 2.1.0 under K241831 and Transpara Density under K232096.
Not for: Autonomous screening decisions, unsupported countries or features, or assuming every Transpara module has the same clearance and intended use.
What to verify before using ScreenPoint Transpara
- Which Transpara module is in scope: Detection, Density, Temporal Comparison, or another breast AI workflow.
- FDA 510(k), CE, local authorization, product version, modality, and intended-use language for 2D or 3D mammography.
- How scores, marks, density output, and prior comparisons appear in PACS, worklists, reports, and radiologist review.
- Local performance by breast density, screening population, scanner vendor, recall rate, false positives, false negatives, and reading-time impact.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- screenpoint-medical.com
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / pdf23
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