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

Point-of-care AI

AI Diagnostics

Curated AI marketplace, POCUS protocol library, and AI-assisted preliminary reads for rural workflows.

Algorithms (demo)

Demo

POCUS protocols: 3
Prelim SLA: < 5m

Rural priority selector

INSIGHT CXR
BoneView
Viz LVO
Lung Cancer Screening AI

INSIGHT CXR

Lunit

X-rayRural value 10/10

BoneView

Gleamer

X-rayRural value 9/10

Viz LVO

Viz.ai

CTRural value 9/10

Lung Cancer Screening AI

Optellum

CTRural value 8/10

AEQD Dose Monitor

Qaelum

CTX-rayFluoroscopyRural value 7/10

AI preliminary read

[AI preliminary — CT] No acute hemorrhage detected on non-contrast series. Correlate clinically; final read by qualified radiologist.

POCUS protocol library

FAST Exam (Focused Assessment with Sonography for Trauma)

Blunt or penetrating abdominal/thoracic trauma

basic

POCUS quality assist

Point-of-capture clip grading for probe orientation and lung curtain completeness (demo).

POCUS tele workflow

Package stills + loop to tele-sonography read pool with escalation triggers (demo).

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

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