ARKA Clinical Decision Support is designed to meet all four criteria for Non-Device CDS under FD&C Act §520(o)(1)(E) and FDA's January 2026 final guidance on Clinical Decision Support Software. Recommendations support, not replace, the clinician's judgment. Every recommendation is anchored in a published guideline or peer-reviewed source, with the basis available for independent review. CLIN emphasizes imaging appropriateness at order entry.
This recommendation is intended to support, not replace, clinical judgment. It is generated by ARKA, software designed to meet the four criteria for Non-Device Clinical Decision Support under FD&C Act §520(o)(1)(E) and FDA's final guidance on Clinical Decision Support Software (January 2026). The clinician is responsible for the final decision.
AIIE Evidence
GCS below 15 after head trauma mandates immediate non-contrast head CT — decision rules do not apply as rule-out tools here.
Any depressed level of consciousness after head trauma is a high-risk feature in every validated decision rule. Non-contrast head CT should be obtained immediately to exclude hemorrhage, contusion, and mass effect.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
The Lancet · 2001doi:10.1016/S0140-6736(00)04561-X
American College of Radiology · 2024