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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
Ultrasound first for renal colic in pregnancy; escalate to MR urography when management hinges on an unconfirmed diagnosis.
Suspected renal colic in pregnancy is imaged with renal and pelvic ultrasound first, accepting moderate sensitivity to avoid fetal radiation. Non-contrast MRI is the second-line study; low-dose CT is a last resort late in workup.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Obstetrics & Gynecology · 2017doi:10.1097/AOG.0000000000002355
New England Journal of Medicine · 2014doi:10.1056/NEJMoa1404446
American College of Radiology · 2024
