FDA Radiology AI Devices

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 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.

Mixed Reality Spine Navigation is an accessory software used with Brainlab's Spine & Trauma Navigation platform. It employs a mixed reality headset (Magic Leap 2 Medtech) to provide surgeons with 2D and 3D floating visualizations of the patient's spine anatomy and tracked surgical instruments during pedicle screw placement surgery, enhancing intraoperative navigation and precision.

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.

The ARVIS Surgical Navigation System assists surgeons during orthopedic surgeries by providing real-time, augmented reality-based visualization and precise intraoperative measurements to aid in positioning and aligning implants. It enhances surgical accuracy in procedures such as knee and hip arthroplasties, improving outcomes and helping surgeons make informed decisions during operations.

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 Primus Spinal Fixation System is a spinal fixation device designed to provide stabilization and immobilization for the thoracic, lumbar, and sacral spine regions. It includes screws, rods, and connectors that can be precisely placed with the aid of navigation instruments compatible with the Medtronic StealthStation System, which uses medical imaging data like CT and MRI scans to assist surgeons in accurate screw placement during spinal surgeries.

SpineAR SNAP is a software device that helps surgeons plan and perform spinal implant surgeries more accurately by transforming traditional 2D medical images into interactive 3D visualizations. It supports pre-operative planning on screens and virtual reality, as well as intra-operative guidance using augmented reality headsets like HoloLens2 and Magic Leap 1. This technology provides enhanced visualization and guidance, improving surgical precision while allowing the surgeon to maintain focus on the surgical field.

The ROSA Knee System is a robotic-assisted surgical device used during total knee replacement surgeries. It helps surgeons precisely place knee implants by using software to define spatial boundaries relative to anatomical landmarks and utilizing a robotic arm to guide bone resections and implant positioning. This system can integrate pre-operative imaging such as X-rays or MRI to plan surgeries more accurately and improve surgical outcomes.