Not for Clinical Use

1. Platform Status

NexaRad is a research and demonstration platform. It is not a clinical diagnostic product. NexaRad has not been cleared, authorized, approved, or reviewed by the U.S. Food and Drug Administration (FDA) or any other regulatory body. No clinical claims are made for any NexaRad module, adapter, or output at this time.

2. No Clinical Decision-Making

No clinical decisions, diagnoses, treatment plans, triage determinations, or patient management actions should be based on NexaRad outputs. The platform does not provide medical advice, interpretation, or recommendations for patient care. Any content generated by the system — including AI findings, report drafts, verifier results, and exports — is for demonstration and research purposes only.

3. Operating Modes

NexaRad supports multiple operating modes to enforce appropriate usage boundaries:

• Demo Mode — Synthetic or de-identified data only. All outputs carry a “Demo / Not for Clinical Use” watermark and disclaimer. No PHI.
• Research Mode — De-identified, IRB-approved, or contracted research data. All outputs carry a “Research / Not for Clinical Use” watermark and disclaimer.
• Clinical Evaluation Mode — Controlled studies with clinician review. Not used as final clinical output unless authorized by protocol. Disabled by default.
• Cleared Clinical Mode — Requires module-specific regulatory clearance or authorization, validated model version, customer contracting, and completed PHI production controls. Not currently active.

4. Watermarking

All reports, exports, and screenshots generated in Demo or Research modes are permanently watermarked with the applicable non-clinical disclosure. Removing or obscuring these watermarks does not change the non-clinical status of the output. Clinical use of watermarked outputs is prohibited.

5. No Performance Claims

NexaRad makes no claims regarding diagnostic sensitivity, specificity, accuracy, turnaround-time improvement, radiologist productivity, or patient outcomes. No module has been validated for clinical performance. Any metrics shown in the platform are research/demo illustrations only and must not be interpreted as clinical evidence.

6. What NexaRad Is and Is Not

NexaRad is: a radiology workflow platform foundation that accepts DICOM studies, organizes metadata, runs research/demo AI analysis adapters, produces structured findings with evidence provenance, and supports clinician review, editing, and report drafting — all under role-based access controls and audit logging.

NexaRad is not: an autonomous diagnostic system, a replacement for radiologist interpretation, a triage or prioritization tool, a clinical decision support device, an FDA-cleared medical device, a HIPAA-certified service, or a substitute for qualified clinical judgment.

7. Related Policies

• Privacy Policy — How we handle data in demo and research modes.
• Terms of Service — Terms governing platform use and PHI prohibition.
• Security — Security architecture and vulnerability reporting.
• Data Boundary — Plain-language explanation of data handling and limitations.

8. Contact

For questions about this notice or the regulatory status of NexaRad, contact [email protected].