Full FDA Non-Device CDS disclaimer

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.

Regulatory rationaleFeature catalogTrust center

Baseline capture kit

Measure your baseline — free.

Send a 90-day extract of imaging orders. We return your RI-RADS distribution, your Documentation Concordance Score, and the single element most often missing from your requisitions. No PHI, no integration, no commitment. If the number isn't there, we'll tell you and we'll stop.

ModeledOffer terms — program design, not a measured outcome claim

  1. Your extract

    De-identified or pre-hashed orders CSV (and optional note text). Patient identifiers are never required.

  2. What you get

    RI-RADS A/B/C/D/X distribution vs published inpatient benchmark; DCS with n and CI; most-missing element type; small-cell suppression for n < 11.

  3. How it runs

    Offline kit your Epic analyst can run inside your firewall. Zero network calls. You can send only aggregates if you prefer.

Request baseline analysisBack to indication reconstruction

Product context: /reconstruction. Evaluation methodology: How ARKA validates.