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Last updated: June 8, 2026
Back to directoryCaristo CaRi-Plaque and CaRi-Heart medical AI product profile
Cardiac CT AI from Caristo that analyzes coronary CTA images for plaque, stenosis, inflammation, and risk reporting in clinician-reviewed workflows.
Medical imaging and radiology
Best fit
Cardiology and imaging programs comparing AI-supported coronary CTA plaque and inflammatory-risk analysis while keeping final interpretation and management decisions with qualified clinicians.
- Primary use case
- AI-assisted coronary CTA plaque analysis, stenosis quantification, coronary inflammation assessment, and cardiovascular risk reporting
- Audience
- Cardiology teams, coronary CTA programs, preventive cardiology clinics, imaging centers, and cardiovascular service lines
- Risk level
- High
- Pricing signal
- Enterprise and provider pricing is not public; verify current product, geography, reimbursement, scan-volume, and implementation 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 Caristo CaRi-Plaque and CaRi-Heart as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Separate CaRi-Plaque from CaRi-Heart and match every deployment to the exact module, software version, country, FDA 510(k) K242240 or other local authorization, trained-user requirement, and intended-use statement. |
|---|---|
| Privacy | Review CCTA de-identification, cloud SaaS transfer, DICOM metadata, regional processing, report delivery, retention, support access, audit logs, customer-controller obligations, BAA or DPA terms, and patient notice language. |
| Evidence | Evaluate ORFAN and other Caristo evidence against the local CCTA population, scanner protocols, age range, plaque burden, inflammatory-risk distribution, cardiologist review, prevention decisions, and downstream testing impact. |
| Workflow | Best governed as cardiologist-reviewed CCTA analysis with explicit rules for report interpretation, discordant findings, prevention escalation, reimbursement documentation, and post-deployment monitoring. |
Where Caristo CaRi-Plaque and CaRi-Heart fits
Caristo describes CaRi-Heart as an AI solution that quantifies coronary inflammation and characterizes plaque from routine CCTA, with secure anonymized transfer and regulatory clearance in the UK, Europe, and Australia; the Caristo site states CaRi-Heart is limited to investigational use in the United States, while FDA records list CaRi-Plaque 510(k) K242240 as a cleared radiological image-processing system for coronary plaque and stenosis analysis.
Not for: Standalone cardiovascular diagnosis, emergency rule-out, revascularization decisions, unsupported CCTA protocols, or treating CaRi-Heart and CaRi-Plaque as having identical U.S. regulatory status.
What to verify before using Caristo CaRi-Plaque and CaRi-Heart
- Which module is in scope: FDA-cleared CaRi-Plaque, CaRi-Heart FAI-Score, CaRi-Heart Risk Score, a research workflow, or a combined regional report.
- FDA 510(k) K242240 status for CaRi-Plaque, CaRi-Heart's local authorization or investigational status, software version, intended use, and trained-operator requirements.
- How CCTA data is de-identified, transferred, processed, retained, returned, and protected under customer agreements, BAA or DPA terms, and regional data-transfer rules.
- Local evidence for scanner mix, image quality, plaque characterization, inflammation scoring, downstream prevention decisions, reimbursement, false reassurance, and over-testing risk.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.caristo.com / cari-heart-technology
- www.caristo.com / coronary-plaque-analysis
- www.accessdata.fda.gov / scripts / cdrh
- www.caristo.com / wp-content / uploads
- www.caristo.com / wp-content / uploads
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