FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

IQ-UIP is an AI-powered computer-aided software designed to analyze non-contrast chest CT scans to detect and notify specialists about radiological findings suggestive of usual interstitial pneumonia (UIP), a type of fibrotic lung disease. It works alongside standard radiological workflows to help clinicians by providing summarized findings via a worklist application, assisting in the evaluation of interstitial lung disease without altering original images or providing diagnostic conclusions itself.

FDA #
K242467
Product Code
QWO

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.

FDA #
K141069
Product Code
JAK
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