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 uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.

FDA #
K193271
Product Code
QFM

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

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.

FDA #
K201020
Product Code
QAS

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

FDA #
K200714
Product Code
LLZ

VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.

FDA #
K200990
Product Code
JAK

InferRead Lung CT.AI is software that helps radiologists detect lung nodules in chest CT scans. It uses AI algorithms to identify and mark nodules, providing measurements and characterization to aid diagnosis, specifically targeting an asymptomatic population. The software integrates with existing PACS systems and assists clinicians by enhancing nodule detection sensitivity and reducing interpretation times.

FDA #
K192880
Product Code
OEB

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

AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.

FDA #
K193300
Product Code
QFM

syngo.CT Lung CAD is an AI-powered software tool that helps radiologists detect solid pulmonary nodules in chest CT scans. Acting as a second reader, it alerts clinicians to potential nodules that might have been overlooked during their initial review, thereby improving diagnostic accuracy and patient care.

FDA #
K193216
Product Code
OEB

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

FDA #
K191550
Product Code
JAK
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