FDA Radiology AI Devices

Rayvolve is an AI-powered software tool that helps radiologists and emergency physicians detect fractures on X-rays of the musculoskeletal system. It analyzes various standard radiographic views of bones like ankle, clavicle, elbow, hip, knee, and more, providing accurate fracture detection to support clinical decision-making.

HealthOST is an AI-powered image processing software that analyzes CT scans of the spine to help clinicians detect and assess musculoskeletal diseases in patients aged 50 and older. It labels vertebrae, measures vertebral height loss, and calculates bone density using Hounsfield Units, providing quantitative data to aid diagnosis and treatment planning without replacing clinical judgment.

Customize is a software tool designed to assist physicians in planning shoulder arthroplasties by visualizing, modifying, and validating 3D models generated from CT scans. It helps communicate treatment options, segments CT data, and manages cases and timelines, aiding clinicians in surgical preparation and decision-making.

BoneView by Gleamer is an AI-powered software that analyzes X-ray images of bones to detect and highlight fractures. It acts as a concurrent reading aid for clinicians, improving the accuracy and confidence of fracture diagnosis from radiographs across a wide range of anatomical areas. By providing clear visual annotations, it helps reduce missed fractures and supports better patient care.

The Micro C Medical Imaging System, M01 by OXOS Medical, Inc. is a handheld, portable mobile X-ray device intended for use by trained clinicians to capture diagnostic images of extremities. It features an AI-based software called AiLARA that recommends power settings and exposure times to optimize image quality and reduce retakes, enhancing clinician efficiency and patient safety.

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.

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.

Preview Shoulder is a pre-operative planning software that helps orthopedic surgeons develop shoulder surgery plans by processing patient CT scans. The software reconstructs 3D models of the shoulder anatomy, allowing surgeons to digitally place implants and generate detailed surgical planning reports, thus aiding surgical preparation without providing diagnostic 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.

FractureDetect (FX) is an AI-powered software that analyzes X-ray images of bones to help doctors detect fractures. It highlights areas on radiographs where fractures are detected, improving accuracy and efficiency in diagnosis for various bone regions in adults.