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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
Apply the Canadian CT Head Rule; GCS 15 patients without rule-positive features do not need CT for post-traumatic headache alone.
After minor head trauma with GCS 15 and no high-risk features, validated decision rules (Canadian CT Head Rule, New Orleans Criteria) identify patients in whom CT can be safely omitted. Imaging decisions should be rule-based rather than reflexive.
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
