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.

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.

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 Medyssey Navigation System is a reusable surgical instrument set designed to work with the Medtronic StealthStation navigation system. It helps surgeons precisely locate anatomical structures during spinal surgeries by integrating with imaging data such as CT or MR-based models, fluoroscopy images, or digitized landmarks. This improves accuracy in placing spinal fixation implants and supports open or minimally invasive procedures.

Op.n Navigation by Ecential Robotics is a surgical navigation system designed to assist surgeons during spinal surgery. It uses intra-operative 3D imaging to help accurately position surgical instruments and implants like pedicle screws in the thoracolumbar spine. This technology improves surgical precision and patient outcomes by providing real-time navigation based on detailed imaging.

The SPINEART Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It integrates with the eCential Op.n PERLA® TL Navigation System, which uses intraoperative 3D imaging, to improve surgical precision in both open and minimally invasive procedures.

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.