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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
Persistent adult neck masses need targeted imaging — ultrasound or contrast-enhanced CT of the neck — and should not be observed without workup.
An adult neck mass persisting beyond two weeks is malignant until proven otherwise, but the initial imaging study is usually ultrasound (with FNA as indicated) or contrast-enhanced CT rather than empiric advanced imaging. The AAO-HNS guideline frames a standardized escalation pathway.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Otolaryngology–Head and Neck Surgery · 2017doi:10.1177/0194599817722550
American College of Radiology · 2024
