Medical imaging and radiology
Elucid PlaqueIQ
FDA-cleared non-invasive plaque analysis software for coronary CTA workflows that reports plaque composition and vessel-level findings.
Last updated: June 14, 2026
Back to directoryCleerly medical AI product profile
AI-enabled CCTA analysis platform for coronary plaque assessment and heart attack prevention workflows.
Medical imaging and radiology
Best fit
Cardiology and imaging teams using CCTA to quantify and track coronary plaque.
- Primary use case
- AI-enabled coronary CT angiography and plaque analysis
- Audience
- Cardiology teams, imaging centers, and cardiovascular risk programs
- Risk level
- High
- Pricing signal
- Enterprise/provider pricing; verify current availability.
- Official sources
- 7 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared Cleerly Labs coronary CTA image-analysis/reporting software; public indications describe Rx-only use by trained medical professionals and no replacement for qualified practitioner judgment. |
|---|---|
| Review route | 510(k) K242338, with earlier Cleerly Labs clearances including K202280 and K190868. |
| Intended use | Software for trained users to review, visualize, segment, measure, and report coronary CTA findings including plaque, stenosis, stent, CTO, dominance, and anomaly-related information. |
| Verification note | Verify the current Cleerly Labs version, CCTA acquisition requirements, user-editable segmentation workflow, report export path, physician-report boundaries, and current FDA database record. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf24 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Cleerly as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Confirm product-specific clearance, Rx-only status, trained-user requirements, indication, eligible CCTA acquisition protocol, and geography before using plaque analysis in a clinical pathway. |
|---|---|
| Privacy | Review coronary CTA upload, cloud processing, image retention, report distribution, authorized users, application access, and data-use terms for cardiology workflows. |
| Evidence | Evaluate evidence for the intended patient population, scanner protocols, plaque metrics, downstream testing, preventive treatment decisions, and follow-up outcomes. |
| Workflow | Best governed as cardiologist-reviewed CCTA analysis feeding structured prevention or treatment-planning workflows, not as autonomous cardiovascular diagnosis. |
Where Cleerly fits
Cleerly describes AI-enabled CCTA coronary plaque analysis for comprehensive and trackable insights; its indications page says Cleerly Labs is Rx-only software for trained medical professionals and should not replace qualified practitioner judgment.
Not for: General cardiovascular diagnosis without clinician interpretation and validated workflow.
What to verify before using Cleerly
- Regulatory status and intended use in your country.
- Scanner and CCTA protocol requirements.
- Clinical evidence and reporting workflow.
- How results inform prevention decisions and follow-up.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- cleerlyhealth.com / plaque-analysis
- cleerlyhealth.com / indications-for-use
- cleerlyhealth.com / providers
- cleerlyhealth.com / ischemia-reinvented
- www.accessdata.fda.gov / cdrh_docs / pdf24
- www.accessdata.fda.gov / cdrh_docs / pdf20
- cleerlyhealth.com / privacy-policy
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