Medical imaging and radiology
Caristo CaRi-Plaque and CaRi-Heart
Cardiac CT AI from Caristo that analyzes coronary CTA images for plaque, stenosis, inflammation, and risk reporting in clinician-reviewed workflows.
Last updated: June 14, 2026
Back to directoryHeartflow medical AI product profile
Non-invasive AI heart-care platform for coronary CTA-derived anatomy, physiology, and plaque information.
Medical imaging and radiology
Best fit
Cardiology and imaging programs using CCTA to evaluate coronary artery disease and support treatment planning.
- Primary use case
- AI-powered coronary CTA analysis, FFRCT physiology analysis, plaque analysis, and coronary roadmap workflows
- Audience
- Cardiology teams, coronary CTA programs, imaging centers, and cardiovascular service lines
- Risk level
- High
- Pricing signal
- Provider and enterprise pricing varies by product, geography, and reimbursement workflow; verify current terms.
- Official sources
- 7 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared AI-based CT analysis software for coronary artery disease workflows; exact scope depends on the Heartflow module. |
|---|---|
| Review route | 510(k), including Heartflow Analysis records such as K213857 and later plaque-analysis clearances. |
| Intended use | Analyzes previously acquired cardiac CT DICOM data for adult patients with suspected coronary artery disease and provides anatomic, plaque, and FFRCT-related outputs depending on the cleared module. |
| Verification note | Separate FFRCT, Plaque Analysis, Roadmap Analysis, indications, image-quality requirements, reimbursement, and cardiologist review rules in procurement materials. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf21 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Heartflow as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Separate FFRCT, plaque, roadmap, and other Heartflow modules because each may have different clearance, indication, contraindication, and reimbursement requirements. |
|---|---|
| Privacy | Review CCTA image submission, cloud analysis, report delivery, retention, access controls, and cardiology-record integration before production use. |
| Evidence | Assess clinical utility for the target coronary-artery-disease population, scanner protocols, image quality thresholds, downstream testing, and treatment changes. |
| Workflow | Best governed as cardiology-reviewed coronary CTA analysis feeding shared decision-making, referral, preventive-care, or cath-lab planning workflows. |
Where Heartflow fits
Heartflow describes AI-powered non-invasive heart-care analysis for coronary CTA, including FFRCT, plaque, and roadmap analysis; company materials include FDA clearance history and a 2025 next-generation plaque-analysis clearance announcement.
Not for: Emergency cardiac diagnosis, unsupported scans, or treatment decisions without cardiologist interpretation and product-specific intended-use review.
What to verify before using Heartflow
- Which Heartflow product is being used: FFRCT, Plaque Analysis, Roadmap Analysis, or another module.
- FDA clearance, indication, required CCTA image quality, contraindications, and geography-specific availability.
- How results are reviewed by cardiology, documented, billed, and incorporated into shared decision-making.
- Evidence for the target patient population, scanner protocols, clinical utility, and downstream testing impact.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.heartflow.com / about
- www.heartflow.com / indications
- www.heartflow.com / press-release / Heartflow-plaque-analysis-and-roadmap-analysis-fda-510k-clearance
- ir.heartflow.com / node / 6481
- www.heartflow.com / wp-content / uploads
- www.heartflow.com / press-release / nextgen-plaque-analysis
- www.accessdata.fda.gov / cdrh_docs / pdf21
Related medical AI products
Medical imaging and radiology
Ultromics EchoGo
FDA-cleared echocardiography AI that analyzes apical four-chamber clips to support detection of heart failure with preserved ejection fraction.
Medical imaging and radiology
Us2.ai
FDA-cleared AI echocardiography platform that automates measurements, disease-detection support, and structured reporting from DICOM echo studies.
Medical imaging and radiology
Gleamer BoneView
Radiology AI product for detecting and highlighting fractures on trauma X-rays inside clinician-reviewed reading workflows.