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
X-ray first for acute shoulder trauma; MRI follows only for specific soft-tissue surgical questions after radiographs.
Acute traumatic shoulder pain starts with radiographs to identify fracture and dislocation. Advanced imaging is a second step driven by surgical questions — suspected acute full-thickness cuff tear in a young patient or persistent symptoms after films.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
American College of Radiology · 2024
British Journal of Sports Medicine · 2015doi:10.1136/bjsports-2014-094148