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
Ottawa-positive ankle injuries get targeted radiographs — ankle series for malleolar findings, foot series for midfoot findings.
Bony tenderness at the malleoli or midfoot landmarks, or inability to bear weight, satisfies the Ottawa ankle rules and indicates radiography of the ankle and/or foot series as directed by the positive element.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
BMJ · 2003doi:10.1136/bmj.326.7386.417
American College of Radiology · 2024