FDA Radiology AI Devices

Videa Dental Assist is an AI-powered software that analyzes intraoral dental X-ray images such as bitewing, periapical, and panoramic radiographs. It assists dental professionals by automatically detecting and localizing suspected dental findings, historical treatments, and normal anatomical features, helping improve diagnostic accuracy and patient management.

DTX Studio Clinic (4.0) is a dental and craniomaxillofacial imaging software that assists clinicians by analyzing 2D intraoral radiographs with AI to detect dental issues such as caries, calculus, and bone loss. It supports diagnostic workflows and treatment planning, including guided implant surgery, by managing and enhancing images from various sources and facilitating image sharing and review.

Adravision Perio is a semi-automated dental image processing software that assists dentists and dental hygienists in measuring mesial and distal bone levels from bitewing and periapical radiographs. The software provides suggested measurements and visual annotations to support clinical decision-making, improving the accuracy and efficiency of dental assessments for adults without primary teeth.

BraveCX is an AI-based software that analyzes adult chest X-ray images to detect pleural effusion and pneumothorax. It helps radiologists prioritize cases with suspected critical findings by flagging suspicious images in the PACS worklist, enhancing workflow efficiency without providing direct diagnostic decisions.

Denti.AI Detect is a computer-assisted detection software designed for dental professionals to assist in identifying dental issues such as caries and periapical radiolucency on 2D dental X-rays. It also helps measure bone levels around teeth, serving as a second reader to improve diagnostic accuracy and support clinical decisions.

DeepTek CXR Analyzer v1.0 is a software tool that helps radiologists detect suspicious regions in chest X-rays. Using AI and deep learning, it highlights abnormal areas related to lungs, pleura, heart, and hardware implants to support clinicians in their diagnosis. It doesn't replace radiologists but acts as an aid to improve detection accuracy and efficiency.

Lung-CAD is an AI-based software designed to assist physicians by analyzing chest X-ray images and identifying regions of lung hyperinflation. It highlights these regions with boxes on the X-ray images to support concurrent reading, improving detection accuracy without replacing clinical diagnosis.

qXR-CTR is an AI-powered software that helps physicians automatically measure the cardiothoracic ratio—the size of the heart relative to the chest—using chest X-ray images. It analyzes images to provide quick, accurate measurements that support clinical decision-making, making the process more efficient for healthcare providers.

Overjet Periapical Radiolucency Assist is an AI-powered software designed to help dentists detect periapical radiolucencies in dental X-ray images, specifically on periapical radiographs. It provides automated, concurrent read assistance to improve diagnostic accuracy, supporting dentists in identifying potential issues in permanent teeth for patients aged 12 and older. The tool acts as a supplementary aid, enhancing clinical decision-making without replacing professional judgment.

Lung-CAD is an AI-powered software that helps physicians by analyzing chest X-rays to identify areas showing interstitial thickening. It highlights these areas with bounding boxes, serving as a concurrent reading aid to improve detection. It does not replace physicians but supports them in interpreting lung images more effectively in adults.