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.

The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

HealthCCSng is a software tool that uses artificial intelligence to automatically detect and measure calcified plaques in the coronary arteries from routine non-gated, non-contrast CT scans. It provides an exact calcium score and categorizes the amount of calcium present, with results integrated into the radiologist's workflow to assist in assessing risk for coronary artery disease.

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.

The uMI Panvivo is a combined PET/CT imaging system designed to provide high-quality functional and anatomical images to help clinicians detect, localize, evaluate, and monitor abnormalities such as tumors, lesions, infections, and other conditions across various body areas. It supports better patient experience with a large bore and advanced iterative reconstruction algorithms aided by deep learning, improving image quality and diagnostic accuracy. Additionally, it assists in radiotherapy planning and interventional radiology procedures.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.

OptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.