Riverain ClearRead CT
FDA-cleared cardiothoracic CT AI suite for lung nodule support, vessel suppression, longitudinal comparison, and incidental CAC scoring.
Last updated: June 13, 2026
Back to directoryOpportunistic CT AI and care-coordination platform that combines FDA-cleared imaging algorithms with workflow automation for follow-up on actionable findings.
Health systems that want to convert routine CT findings into supervised preventive-care, referral, counseling, DEXA, echocardiography, cardiology, or surveillance workflows.
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| Status | Multiple FDA-cleared CT-analysis algorithms are described in public materials; status and scope vary by Bunkerhill feature. |
|---|---|
| Review route | 510(k), including records such as K230223 for iCAC, K242295 for BMD, K243229 for AVC, K243779 for AAQ, K250662 for MAC, and K260167 for Contrast AVC. |
| Intended use | Analyzes specified routine CT studies for defined calcification, bone-density, or aortic measurements and makes outputs available to physicians for review; outputs should not be used as standalone diagnosis or treatment decisions. |
| Verification note | Procurement should map every Carebricks workflow to a specific cleared algorithm, version, CT protocol, patient age range, output, clinician-review step, and follow-up policy. |
| Source | www.accessdata.fda.gov / scripts / cdrh |
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Bunkerhill Carebricks as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat each Bunkerhill algorithm as a separate high-risk imaging SaMD workflow. Match the deployed feature, anatomy, CT acquisition type, age range, output, 510(k), and physician-review language before connecting it to outreach or care-coordination automation. |
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| Privacy | Review DICOM routing, EHR integration, edge versus cloud processing, re-identification, patient outreach data, scheduling messages, support access, retention, audit logs, BAA terms, security certifications, and whether public privacy language differs from contracted clinical data terms. |
| Evidence | Use FDA summaries, vendor validation materials, and local retrospective pilots to assess algorithm performance, incidental finding burden, false-positive and false-negative risk, follow-up completion, equity, and whether downstream interventions improve care rather than only increasing work. |
| Workflow | Best governed by radiology, cardiology, primary care, bone health, vascular, imaging IT, privacy, and patient-access teams defining review queues, signoff requirements, patient communication, referral ownership, downtime procedures, and post-launch monitoring. |
Bunkerhill describes Carebricks workflows that use FDA-cleared algorithms to detect elevated CAC, low bone density, aortic valve calcification, abdominal aortic enlargement, and other findings on routine CT studies, then coordinate review, outreach, and follow-up. Its BMD clearance page says Bunkerhill BMD analyzes spinal bone structures from non-contrast abdominal CT in adults 30 and older and can support detection-to-follow-up workflows through Carebricks. FDA records list Bunkerhill AAQ as automated radiological image processing software, K242295 for BMD, K260167 for Contrast AVC, and K250662 for MAC, with physician-review and non-standalone-use language buyers should preserve in deployment policy. Public security and privacy materials reference HIPAA, SOC 2 Type II, ISO 27001, and personal-information handling that must be verified contractually for clinical data use.
Not for: Standalone diagnosis, replacing radiologist or physician review, automated outreach without local policy approval, or use where CT indication, device version, consent, PHI flow, and follow-up ownership are undefined.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.