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 CAC is a software that analyzes non-contrast chest CT scans to quantify calcified plaques in coronary arteries, calculate the Agatston score, and provide risk stratification based on calcium scoring, age, and gender. It helps radiologists and cardiologists by supporting image storage, transfer, and display, facilitating clinical decision-making for coronary artery disease risk assessment.

FDA #
K233211
Product Code
QIH

AVIEW Lung Nodule CAD is an AI-powered software designed to help radiologists detect lung nodules on chest CT scans. It automatically identifies nodules between 3 to 20 mm in diameter, providing an additional review layer to ensure suspicious nodules are not overlooked. This tool integrates with medical imaging systems and has been clinically tested to improve detection accuracy and reduce the time radiologists spend reviewing CT scans, ultimately aiding early diagnosis of lung conditions.

FDA #
K221592
Product Code
OEB

AView LCS by Coreline Soft Co., Ltd. is a medical software tool that helps clinicians review, analyze, and report on thoracic CT scans. It automatically detects and measures lung nodules, calculates malignancy risk, supports follow-ups with nodule matching, and generates diagnostic reports. This improves the accuracy and efficiency of lung nodule assessment and lung cancer screening.

FDA #
K201710
Product Code
LLZ

AVIEW LCS by Coreline Soft Co., Ltd. is a diagnostic software tool that reviews, analyzes, and reports on thoracic CT images to help clinicians characterize lung nodules. It automatically measures nodule size, volume, density, and growth over time, integrates with FDA-cleared CAD for nodule detection, and provides lung cancer risk scoring and standardized Lung-RADS categorization. This helps clinicians detect, monitor, and manage lung nodules more accurately and efficiently.

FDA #
K193220
Product Code
LLZ
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