Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 11, 2026
Back to directoryNanox.AI HealthCCSng medical AI product profile
FDA-cleared cardiac AI solution that analyzes routine chest CTs for coronary artery calcium and returns calcium scoring or detection-category outputs for clinician review.
Medical imaging and radiology
Best fit
Imaging programs that want opportunistic cardiovascular risk detection from existing CT studies while preserving radiologist review, cardiology follow-up, and local preventive-care protocols.
- Primary use case
- FDA-cleared AI post-processing of routine non-gated, non-contrast CT studies to identify coronary artery calcium and add CAC scoring or category output to radiology and follow-up workflows
- Audience
- Radiology groups, imaging centers, health systems, cardiology programs, preventive-care teams, population-health leaders, and CT workflow owners
- Risk level
- High
- Pricing signal
- Public pages emphasize ROI and cardiology revenue but do not publish contract pricing; verify current software version, deployment, PACS/EMR integration, support, privacy, reimbursement, and service terms.
- Official sources
- 4 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 Nanox.AI HealthCCSng as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated radiological post-processing software; match use to the exact cleared HealthCCSng version, patient age, CT study type, output type, radiologist review boundary, and non-standalone decision language. |
|---|---|
| Privacy | Review DICOM routing, cloud processing, PACS and EMR interfaces, PHI and metadata retention, support access, audit logging, cybersecurity materials, BAA terms, and model-update governance before routing production scans. |
| Evidence | Validate against local CT protocols, scanner vendors, calcium prevalence, radiology reporting patterns, cardiology follow-up capacity, false-positive burden, missed disease, and patient outcomes rather than relying only on clearance or vendor case studies. |
| Workflow | Best governed as opportunistic imaging detection feeding radiologist-reviewed reports and predefined cardiovascular follow-up pathways, with ownership across radiology, cardiology, primary care, quality, privacy, and IT. |
Where Nanox.AI HealthCCSng fits
Nanox describes its AI Cardiac Solution as FDA 510(k)-cleared and CE-marked software that analyzes routine non-contrast, non-ECG-gated chest CT scans, measures and visualizes coronary calcified plaque, and integrates output into radiology reports and EMR systems. FDA 510(k) K241440 describes HealthCCSng as post-processing software for routine non-gated, non-contrast CT studies that include the entire heart in adults age 30 to 85, and states results are not intended for standalone risk attribution or clinical decision-making.
Not for: Standalone coronary risk attribution, autonomous clinical decision-making, diagnosis without clinician assessment, unsupported CT protocols, patients outside the cleared age and study scope, or deployments without CAC follow-up governance.
What to verify before using Nanox.AI HealthCCSng
- Whether the deployed version is HealthCCSng V2.0 or another Nanox.AI cardiac solution, with the exact FDA 510(k), CE, intended-use, age, CT protocol, output, and radiologist-workflow language.
- Compatibility with local CT acquisition, slice thickness, DICOM routing, PACS worklists, report insertion, EMR integration, cardiology notification, failed-study handling, and downtime workflows.
- Cloud or on-prem processing path, DICOM metadata, PHI handling, retention, support access, audit logs, cybersecurity documentation, BAA terms, and whether local scans are used for product improvement.
- Local performance for scanner mix, calcium prevalence, false positives, false negatives, non-cardiac chest CT indication mix, incidental finding burden, radiologist edit rate, and cardiology follow-up completion.
- How outputs trigger preventive-care outreach, calcium score documentation, patient communication, ordering responsibility, primary-care or cardiology handoff, and monitoring for over-testing or inequitable follow-up.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.nanox.vision / ai-cardiac-solution
- www.nanox.vision / ai
- investors.nanox.vision / news-releases / news-release-details
- www.accessdata.fda.gov / cdrh_docs / pdf24
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