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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 PECARN: image high-risk children, observe intermediate-risk children, and avoid CT in rule-negative children.
For children 2 years and older with minor head trauma, the PECARN rules stratify the risk of clinically important traumatic brain injury. CT is reserved for high-risk children; intermediate-risk children are candidates for observation before imaging.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
The Lancet · 2009doi:10.1016/S0140-6736(09)61558-0
The Lancet · 2012doi:10.1016/S0140-6736(12)60815-0
Image Gently Alliance · 2024
