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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
Every recommendation from the ARKA Imaging Intelligence Engine links here — a plain-language synthesis per clinical scenario, with the underlying society guidelines, USPSTF statements, and peer-reviewed literature cited beneath. 113 topics · Knowledge Matrix v1.0.0.
113 topics of 113 across the AIIE Knowledge Matrix
Looking for the ML feature documentation behind ARKA-CLIN scoring? Feature Rationale Catalogue →