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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.

SKOUT system

Iterative Health
510k5/9/2025

The SKOUT system is an AI-powered software device that helps gastroenterologists detect potential colorectal polyps in real-time during colonoscopy procedures. It highlights suspected polyps on the endoscopic video feed to assist doctors in colorectal cancer screening and surveillance, improving detection accuracy without replacing clinical judgment.

FDA #
K251126
Product Code
QNP
Modality:Mixed ModalityTask:DetectionBody Region:AbdominalTarget Condition:Lesion

EW10-EC02 Endoscopy Support Program

FUJIFILM Corporation
510k12/15/2023

The EW10-EC02 Endoscopy Support Program is an AI-driven software tool designed to support endoscopists by detecting colon polyps and adenomas in real time during standard colonoscopy exams. It processes real-time endoscopic video images from White Light Imaging and Linked Color Imaging to highlight potential lesions, helping clinicians improve diagnosis and patient outcomes without replacing clinical judgment.

FDA #
K230751
Product Code
QNP
Modality:Mixed ModalityTask:DetectionBody Region:AbdominalTarget Condition:Lesion
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