FDA Radiology AI Devices

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.

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.

PhantomMSK Trauma is a software tool that helps surgeons during orthopedic trauma surgeries by providing precise measurements and image analysis of fluoroscopic images. It assists in the intraoperative positioning of implants relative to bone structures, helping improve surgical accuracy without primary image interpretation.

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.

aBSI is a software-only medical device designed to quantitatively assess and analyze skeletal disease burden on bone scans from nuclear medicine imaging. It helps healthcare professionals by automatically detecting and quantifying lesions to support clinical decision-making, particularly in oncology, by measuring disease extent in the skeleton.

The UNiD Spine Analyzer is a software tool that helps healthcare professionals view, measure, and analyze medical images related to the spine. It assists in planning orthopedic surgeries by allowing surgeons to perform measurements and plan the placement of surgical implants. This tool enhances surgical planning accuracy and efficiency for spine treatments.

The UNiD Spine Analyzer is a web-based software designed to help healthcare professionals view and measure spine-related images, and plan orthopedic surgeries. It assists with measurements, surgical planning including osteotomies, and templating implants, enabling surgeons to prepare and validate plans for patient-specific spine implants.