EFAI ERSuite CT Appendicitis Assessment System

Radiological computer-aided triage and notification software that analyses contrast-enhanced abdominal CT images with an artificial-intelligence algorithm, in parallel to standard-of-care interpretation, and notifies hospital networks and trained clinicians of cases with suspected positive findings of appendicitis for workflow prioritisation; it does not alter the original image and is not intended as a diagnostic device.

FDA Submission Metadata

Submission number

K253163

Decision date

April 2026

FDA panel

Radiology

Product code

QAS

This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.

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Regulatory Approvals