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 rationale Feature catalog Trust center

Population analytics

Rural Intelligence

Imaging desert mapping, outcome correlation, predictive facility risk, and research-ready exports.

Regions tracked

Demo

Outcome model: v0.1
Data freshness: 24h

Outcome correlation

moderate risk

Transfer delay (minutes)75

Transfer delay 75 minutes vs composite outcomes — illustrative association (demo).

Facility access risk (demo model)

AMBER · 60

Demo model using staffing FTE and modality gaps for Prairie View Community Hospital.

Darker regions have fewer nearby imaging options — lower access scores mean longer travel for patients.

Population health analytics

Screening adherence62%up

Transfer for advanced imaging18/1000flat

Research data platform

Synthetic

Federated cohort builder for rural imaging outcomes with IRB-ready export stubs (demo).

Cohort fieldsImaging access scoreTransfer delayScreening adherence

Preview · 3 regions · 2 fields

Northwest Kansas (22/100) · Oklahoma Panhandle (15/100) · Mississippi Delta (8/100)

All patients, orders, and outcomes on this page are synthetic (ARKA-DEMO-001); no real patient data.

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