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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
Uncomplicated pancreatitis needs RUQ ultrasound for gallstone etiology — not an admission CT — when pain and lipase establish the diagnosis.
Acute pancreatitis is diagnosed by two of three criteria (pain, lipase >3× ULN, imaging); when pain and lipase suffice, early CT is unnecessary. Right upper quadrant ultrasound is indicated in all first episodes to assess for gallstones as the etiology.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
American Journal of Gastroenterology · 2013doi:10.1038/ajg.2013.218
Gut · 2013doi:10.1136/gutjnl-2012-302779
American College of Radiology · 2024
