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
Choose radiation-free modalities first in children, apply validated decision rules (PECARN), and use child-dosed protocols when CT is genuinely needed.
Children are more radiosensitive than adults and have more years for stochastic effects to manifest; cohort data link childhood CT exposure to small but measurable increases in leukemia and brain tumor risk. Ultrasound-first and MRI-preferred pathways, decision rules, and child-sized CT protocols are the stewardship toolkit.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
The Lancet · 2012doi:10.1016/S0140-6736(12)60815-0
Image Gently Alliance · 2024
The Lancet · 2009doi:10.1016/S0140-6736(09)61558-0