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.

AVIEW is a software product that assists physicians by providing quantitative analysis of CT images for lung and cardiac evaluation. It offers segmentation of lung structures, characterization and measurement of lung nodules, calcium scoring of coronary arteries, and integrates computer-aided detection tools. It can be used both on-premises and in cloud environments, supporting remote access via mobile devices or browsers. This software enhances diagnostic accuracy and aids in patient management by automating complex image analysis tasks.

FDA #
K243689
Product Code
QIH

qCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.

FDA #
K240740
Product Code
QIH

AVIEW is a medical imaging software by Coreline Soft that helps clinicians analyze CT scans of the lungs and heart. It automatically segments lung structures, characterizes lung nodules with detailed measurements, and provides calcium scoring of coronary arteries to assess cardiovascular risk. It integrates with AI-based CAD tools and offers cloud and mobile access, making it easier and faster for doctors to diagnose lung and heart conditions.

FDA #
K214036
Product Code
QIH
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