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.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is an advanced CT scanner designed to produce cross-sectional images of various body regions, including head, whole body, cardiac, and vascular areas. It integrates deep learning for image reconstruction to enhance image quality and reduce noise, and includes software for dual energy analysis to differentiate tissue types based on their chemical composition. This aids clinicians in lung cancer screening and detailed anatomical evaluation, supporting early diagnosis and treatment.

FDA #
K223028
Product Code
JAK

The uCT ATLAS with uWS-CT-Dual Energy Analysis is a multi-slice CT scanner designed for producing cross-sectional images of the whole body and specific organs using advanced imaging technology. It features fast scanning with high spatial and temporal resolution, low radiation dose, and AI-based enhancements for image quality and patient positioning. Its dual energy analysis software helps differentiate tissue composition using CT images acquired at different energy levels, aiding diagnostic insights.

FDA #
K203448
Product Code
JAK

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.

FDA #
K193073
Product Code
JAK
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