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
Low-dose non-contrast CT confirms renal colic; an ultrasound-first strategy is a guideline-supported alternative for typical presentations.
Low-dose non-contrast CT is the definitive study for suspected nephrolithiasis, but the landmark Smith-Bindman trial showed ultrasound-first strategies achieve equivalent outcomes with less radiation — CT can follow selectively.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
New England Journal of Medicine · 2014doi:10.1056/NEJMoa1404446
Journal of Urology · 2016doi:10.1016/j.juro.2016.05.091
American College of Radiology · 2024