FDA Radiology AI Devices

The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.

Mobius3D (4.1) is a software tool designed for radiation therapy clinics to perform quality assurance, treatment plan verification, and patient alignment analysis. It calculates three-dimensional radiation dose distributions based on treatment plans and imaging data, helping clinicians verify and ensure accurate radiation therapy without directly interacting with the delivery system or patients.

The P-Cure Proton Therapy System (PPTS) is a medical device that produces and delivers proton beam radiation to treat patients with localized tumors and conditions in the head, neck, and thorax. It improves treatment accuracy by using advanced image-guided and robotic patient positioning, including CT and X-ray imaging, helping clinicians precisely target tumors while minimizing damage to surrounding tissues.

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 Intracavitary/Interstitial System by Varian Medical Systems is a medical device used in cancer treatment for the uterus, cervix, and vagina. It employs HDR or PDR brachytherapy, guiding radioactive sources via hollow catheters and needles for precise radiation delivery, helping clinicians target tumors effectively while minimizing exposure to surrounding tissues.

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.

RayCare (2024A SP1) is a software system designed to support cancer treatment by assisting clinicians with treatment planning, management, scheduling, and follow-up for radiation therapy and oncology care. It includes an image viewer for reviewing and annotating images related to patient positioning during treatment, aiding clinicians in delivering precise radiotherapy treatment.

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.

The Klarity SGRT System is a non-invasive, surface-guided radiation therapy device that uses 3D cameras and advanced software to continuously monitor patient positioning and breathing during radiotherapy. It helps clinicians accurately position patients and track respiratory motion to optimize treatment delivery and minimize radiation exposure to healthy tissues.