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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
Suspected orbital or intracranial complication of sinusitis is an emergency — contrast-enhanced CT immediately, MRI for intracranial extension.
Sinusitis with proptosis, ophthalmoplegia, vision change, severe headache, or neurologic findings signals orbital or intracranial extension. Contrast-enhanced CT of the sinuses and orbits is obtained emergently; MRI adds sensitivity for intracranial complications.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Clinical Infectious Diseases · 2012doi:10.1093/cid/cis803
Otolaryngology–Head and Neck Surgery · 2015doi:10.1177/0194599815572097
American College of Radiology · 2024
