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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
CT for pancreatitis severity assessment is most informative ≥72 hours after onset — image deterioration, not the diagnosis itself.
In severe acute pancreatitis or clinical deterioration, contrast-enhanced CT performed 72 hours or more after onset characterizes necrosis and local complications per the revised Atlanta classification. Very early CT underestimates necrosis and rarely changes management.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Gut · 2013doi:10.1136/gutjnl-2012-302779
American Journal of Gastroenterology · 2013doi:10.1038/ajg.2013.218
American College of Radiology · 2024
