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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
Any Canadian CT Head Rule high-risk feature after adult head trauma indicates immediate non-contrast CT.
Adults with head trauma and any high-risk feature — GCS <15, suspected open or depressed skull fracture, signs of basilar skull fracture, repeated vomiting, age ≥65, or dangerous mechanism — require non-contrast head CT per the Canadian CT Head Rule.
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
New England Journal of Medicine · 2000doi:10.1056/NEJM200007133430204
American College of Radiology · 2024
