FDA Radiology AI Devices

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.

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.

OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.

The Altus Spine Navigation System is a set of reusable surgical instruments designed to assist surgeons in accurately placing pedicle screws during spinal surgery. It works together with a navigation system that uses medical images like CT or MRI scans to help locate anatomical landmarks, improving precision in both open and minimally invasive procedures. This system helps enhance surgical accuracy and patient safety by guiding screw placement in the spine.

The Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.

The Mako Total Hip Application 5.0 is a surgical assistive system that uses CT image data to create a 3D model of a patient's hip anatomy, helping surgeons plan and perform total hip replacement surgeries with high precision. It incorporates a robotic arm and software to guide implant placement within software-defined boundaries, improving surgical accuracy and patient outcomes.

The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.

The NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.

The TMINI Miniature Robotic System is a robotic-assisted surgical device designed to help surgeons accurately plan and execute total knee replacement surgeries. It uses preoperative CT scans to create 3D bone models, allowing precise implant positioning through software planning and robotic guidance. The system enhances surgical accuracy and efficiency by using AI-enhanced image segmentation, intraoperative tracking, and spatial boundary definition during surgery.

The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.