FDA Radiology AI Devices

CEPHX is a software tool designed for orthodontists that uses AI to analyze cephalometric x-ray images. It automatically identifies important anatomical landmarks on 2D x-rays, aiding in diagnosis, treatment planning, and patient consultation for individuals over 14 years old. This helps clinicians effectively monitor and simulate orthodontic treatment progress.

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.

RBknee is an AI-powered software that automatically analyzes knee X-ray images to measure joint space width and assess signs of knee osteoarthritis. It provides objective measurements and standardized grading to help medical professionals in evaluating knee osteoarthritis severity, supporting diagnosis and treatment decisions.

Volpara Imaging Software is an AI-driven tool that processes raw digital mammography and tomosynthesis images to generate detailed breast density maps and quantitative metrics. It helps healthcare professionals assess breast composition by providing volumetric measurements and BI-RADS density categories as adjunctive information in breast cancer screening and assessment.

Overjet Dental Assist is a software designed to assist dental professionals by semi-automatically measuring bone levels on dental bitewing and periapical radiographs. It helps by automating the measurement process to support diagnosis and treatment planning but is not intended to replace full patient evaluation or diagnosis by professionals.

HealthJOINT is a software product that assists clinicians by using artificial intelligence to create 3D models of knee bones from standard 2D X-ray images. This helps surgeons with preoperative planning for knee surgeries by providing detailed anatomical landmarks and accurate bone reconstructions, improving clinical assessment and surgical preparation.

KOALA is an automated software that helps medical professionals analyze knee X-rays by measuring joint space width and identifying radiographic signs of osteoarthritis. It assists clinicians in evaluating knee health and aids diagnosis, improving efficiency and accuracy in managing osteoarthritis cases.

Volpara Imaging Software is a tool designed to analyze raw digital mammography and tomosynthesis images to calculate volumetric breast density. It provides quantitative measurements and density maps to assist healthcare professionals in evaluating breast tissue composition. The software operates on a Windows server outside the patient environment and supports clinical decision-making by providing adjunctive information on breast density, aiding in breast cancer screening assessments.

Quantra is a software tool designed to analyze digital mammographic images and estimate breast tissue composition. It categorizes breast density in a way that aligns with BI-RADS breast composition reporting standards to help radiologists assess breast tissue, aiding consistent reporting for breast cancer screening and diagnosis support, though it is not a diagnostic aid itself.

Volpara Imaging Software is a medical imaging application designed to analyze digital mammography and tomosynthesis images. It generates detailed breast density maps and calculates volumetric breast density, helping healthcare professionals assess breast tissue composition. The software provides numerical breast density values and BI-RADS categories as adjunctive information, supporting the diagnostic process.