Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 13, 2026
Back to directoryRiverain ClearRead CT medical AI product profile
FDA-cleared cardiothoracic CT AI suite for lung nodule support, vessel suppression, longitudinal comparison, and incidental CAC scoring.
Medical imaging and radiology
Best fit
Chest CT and lung-screening programs that need radiologist-supervised nodule analysis, prior comparison, structured reporting, and opportunistic cardiovascular-risk signal workflows.
- Primary use case
- Cardiothoracic CT AI suite for vessel suppression, pulmonary nodule detection and comparison, reporting support, coronary artery calcium scoring on ungated non-contrast chest CT, and research-use lung tissue analysis
- Audience
- Radiology groups, lung cancer screening programs, cardiothoracic imaging teams, imaging IT leaders, and health systems evaluating chest CT AI support
- Risk level
- High
- Pricing signal
- Enterprise pricing is not public; request current module, license, PACS/reporting integration, CAC reimbursement, support, security, and deployment terms.
- Official sources
- 5 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared ClearRead CT functions for chest CT workflows; some displayed lung tissue analysis content is marked research use only by Riverain. |
|---|---|
| Review route | 510(k), including ClearRead CT predicate K161201 and ClearRead CT Compare K221612; Riverain also announced FDA-cleared CAC scoring technology for ungated non-contrast chest CT in 2024. |
| Intended use | Supports radiologists with pulmonary nodule detection, characterization, and comparison during review of screening and surveillance low-dose chest CT examinations, with additional module scope requiring product-specific review. |
| Verification note | Confirm the installed module, software version, current FDA database record, CT acquisition requirements, report export behavior, and whether CAC or lung tissue outputs are cleared for the planned clinical use. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf22 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Riverain ClearRead CT as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as high-risk radiology SaMD. Separate cleared ClearRead CT functions from research-use lung tissue analysis, match local use to FDA indications, and review any CAC reporting or reimbursement workflow before production launch. |
|---|---|
| Privacy | Review PACS routing, DICOM metadata, prior-study access, generated series and reports, web API or HL7 exports, user logs, retention, support access, hosting, BAA/security documentation, and any external AI platform distribution path. |
| Evidence | Assess module-specific evidence for nodule detection, comparison accuracy, vessel suppression, reading time, missed-nodule reduction, CAC scoring accuracy, follow-up outcomes, and performance on local scanners and screening populations. |
| Workflow | Best governed as radiologist-supervised chest CT support with clear rules for nodule follow-up, CAC result communication, report insertion, failed-study handling, incidental finding ownership, and post-deployment quality monitoring. |
Where Riverain ClearRead CT fits
Riverain describes ClearRead CT as a cardiothoracic AI suite for chest CT that supports vessel suppression, pulmonary nodule detection and comparison, reporting integration, and incidental coronary artery calcium scoring on ungated non-contrast chest CT. Riverain says ClearRead CT is used for lung cancer screening and incidental CAC scoring, while labeling lung tissue analysis as research use only on the product page. FDA K221612 summarizes ClearRead CT Compare as an extension of Riverain's FDA-cleared ClearRead CT device and describes support for pulmonary nodule detection and characterization during screening and surveillance low-dose chest CT review. Riverain's December 2024 announcement says new FDA-cleared CAC scoring technology can provide CAC scores on ungated non-contrast chest CT scans.
Not for: Autonomous diagnosis, unsupported chest CT protocols, interpreting research-use lung tissue analysis clinically, or deployment without radiologist review, FDA-intended-use checks, and follow-up governance.
What to verify before using Riverain ClearRead CT
- Which ClearRead CT module is enabled, including vessel suppression, nodule detection, compare, CAC scoring, reporting integration, or any research-use lung tissue analysis.
- Exact FDA clearance, predicate record, intended-use language, slice-thickness limits, contrast and non-contrast assumptions, screening versus surveillance population, and research-use exclusions.
- How DICOM routing, prior-study matching, generated series, summary reports, HL7 or web API exports, radiology-report insertion, retention, and audit logs are handled.
- How pulmonary nodules, discordant outputs, failed studies, CAC scores, incidental findings, and follow-up recommendations are reviewed, documented, communicated, and monitored.
- Local validation plan for nodule sensitivity, missed nodules, false positives, reading time, CAC reporting uptake, downstream testing, equity, radiologist workload, and alert or reporting burden.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.riveraintech.com
- www.riveraintech.com / clearread-ct-chest
- www.riveraintech.com / new-technology-from-riverain-adds-coronary-artery-calcification-scoring-to-ungated-chest-ct-scans
- www.accessdata.fda.gov / cdrh_docs / pdf22
- www.riveraintech.com / the-power-of-clearread
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