FDA Radiology AI Devices

Velmeni for Dentists (V4D) is a computer-assisted detection software that helps dentists identify dental caries, restorations, fixed prostheses, and implants in various types of dental radiographs such as bitewing, periapical, and panoramic images. It uses machine learning algorithms to analyze radiographs and highlight areas of interest, providing additional information to aid clinical decisions without replacing dentist judgment.

Overjet Caries Assist-Pediatric is an AI-powered software designed to assist dentists by automatically detecting and outlining dental caries in bitewing and periapical radiographs of pediatric patients aged 4-11. It provides additional visual cues to support clinical diagnosis but is not a replacement for the dentist's comprehensive review and judgment.

qXR-LN is an AI-based software device that analyzes frontal chest X-rays to detect and mark suspected lung nodules between 6 and 30 mm. It acts as a second reader to assist physicians like radiologists and pulmonologists, providing adjunctive information to improve detection accuracy without substituting the original image or clinical judgment.

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.

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.

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.

VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.