FDA Radiology AI Devices

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.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.

The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are surgical navigation tools that use fluoroscopic 2D and CT 3D imaging to precisely guide the placement of surgical instruments and implants during spine surgery. By registering images intraoperatively, they help surgeons perform accurate and safe spinal implant procedures, such as lumbar pedicle screw placement, improving surgical outcomes.

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.