FDA Radiology AI Devices

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.

MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.

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.

MySegmenter (v2.0.0) is a medical imaging software that converts CT and MRI scans into 3D anatomical models for surgical planning and educational use, specifically in orthopedic and craniomaxillofacial cases. It helps clinicians visualize and prepare for surgeries by creating accurate, patient-specific 3D models, though it is not intended for use in the operating room.

Merge Universal Viewer (MUV) is a software application that provides healthcare professionals internet access to view, analyze, and share medical images from multiple imaging modalities. It supports diagnostic workflows by enabling display and manipulation of radiological images, and can output digital files for 3D printing. The viewer facilitates image review, reporting, and data sharing, thus improving accessibility and efficiency in radiology departments.

Oncospace is a software tool designed to help radiation oncologists and dosimetrists plan cancer treatments more efficiently. It uses machine learning to predict dose objectives for organs at risk based on patient anatomy, assists in setting up treatment protocols, and integrates with treatment planning systems to optimize and review radiotherapy plans. This helps clinicians design safer and more effective radiation schedules for patients with cancers in various body regions.

RayStation and RayPlan are advanced software systems designed for radiation therapy planning and medical oncology. They help clinicians propose and optimize treatment plans based on patient imaging data, improving the delivery of safe and effective radiation doses. The software supports a range of radiotherapy techniques, including photon and proton therapies, and incorporates sophisticated dose calculation and optimization algorithms to tailor treatments to individual patients' needs.

PeekMed web is an AI-powered software system that helps healthcare professionals perform pre-operative planning for various surgical procedures using patients' imaging studies. It operates in 2D and 3D environments with support for musculoskeletal regions and incorporates automated AI models for bone segmentation and landmarking, improving efficiency and accuracy in surgical planning.

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.