FDA Radiology AI Devices

MuscleView 2.0 is an MRI imaging system that aids clinicians in visualizing and analyzing muscle tissue. It helps radiologists and healthcare providers obtain detailed images of muscle anatomy for diagnosis and treatment planning.

3D-SHAPER is a medical device that analyzes imaging data to measure bone density in three dimensions. It helps clinicians assess bone health more accurately, which is important for diagnosing conditions like osteoporosis and planning treatments.

OsteoSight™ Hip (v1) is a radiology software designed to opportunistically evaluate low bone mineral density from medical images, helping clinicians identify patients at risk for osteoporosis and related fractures.

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.

The UNiD™ Spine Analyzer by Medicrea International is a software tool designed to automatically process radiological images of the spine. It helps clinicians by providing detailed analysis of spinal images, which facilitates diagnosis and treatment planning for spinal conditions.

The REMEX Xcam6 is a portable, handheld mobile X-ray system designed for hospital or clinic use to capture diagnostic X-ray images of patient extremities. It can be used with a flat panel detector to acquire, display, and manipulate images. It enables clinicians to obtain high-quality radiographic images conveniently and safely, aiding the diagnosis of various conditions affecting extremities.

The PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS are portable digital X-ray systems designed to provide high-quality diagnostic images of body extremities. These battery-operated portable X-ray devices use flat-panel detectors and advanced image acquisition software to produce clear, digital radiographs, aiding fast and accurate clinical diagnosis. They are intended for use in varied healthcare settings including field locations and tele-radiology setups, operated by trained medical professionals.

CORIOGRAPH Pre-Op Planning and Modeling Services is software designed to assist surgeons with preoperative planning for orthopedic surgeries such as knee, hip, and shoulder replacements. It uses patient imaging scans to create personalized surgical plans and allows surgeons to simulate and modify implant positioning before surgery, helping improve precision and surgical outcomes.

The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.

TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.