FDA Radiology AI Devices

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.

BriefCase is an AI-powered software that helps radiologists prioritize cervical spine CT scans by flagging possible fractures. It runs alongside standard image interpretation, notifying clinicians quickly about suspected cases to enable faster patient management, but it is not used for final diagnosis. This helps improve workflow efficiency and timely attention to urgent cases.

Bone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.

OsteoDetect is an AI-driven software that helps clinicians detect distal radius fractures on adult wrist X-rays. It analyzes both posterior-anterior and lateral radiographs, highlighting potential fractures with bounding boxes to assist healthcare providers in diagnosing wrist injuries more accurately and quickly. The software serves as an adjunct, supporting clinical decision-making but not replacing the clinician's judgment.

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.