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
High-risk or non-clearable cervical trauma gets CT of the cervical spine; plain films are inadequate in this group.
Trauma patients with high-risk features under the Canadian C-Spine Rule or who cannot be clinically cleared (NEXUS-positive) require imaging, and multidetector CT has replaced radiographs as the initial study in high-risk adults.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
JAMA · 2001doi:10.1001/jama.286.15.1841
New England Journal of Medicine · 2000doi:10.1056/NEJM200007133430203
American College of Radiology · 2024