FDA Radiology AI Devices

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

Vitesse (5.0) is a treatment planning software designed for medical professionals to assist in planning, guiding, optimizing, and documenting high-dose-rate brachytherapy procedures. It supports real-time ultrasound guidance, image import and export via DICOM standards, and visualization of complex imaging data including PET and MR scans. This software helps clinicians create and manage radiation treatment plans accurately and efficiently, improving patient care in radiation therapy.

Ethos Treatment Management 3.0 and Ethos Treatment Planning 2.0 from Varian Medical Systems are software applications designed to assist clinicians in managing, generating, and modifying radiation therapy treatment plans. They incorporate AI-based segmentation algorithms to aid in contouring anatomical structures to improve and streamline radiation therapy planning and monitoring. These tools help improve accuracy and efficiency in radiation treatment for cancer and other diseases requiring radiation therapy.

AI Segmentation is a cloud-based software product that uses artificial intelligence to automatically segment anatomical structures from CT images. It is designed to assist medical professionals in radiation therapy treatment planning by providing automated contours of organs in regions such as the head and neck, thorax, pelvis, and abdomen. The segmented structures can be reviewed, edited, and approved by qualified treatment planners and physicians to streamline planning and improve accuracy.

AI Segmentation by Varian Medical Systems is a cloud-based AI software tool that segments patient anatomical structures from CT scans to assist radiation therapy treatment planning. It automatically delineates organs at risk in regions such as head and neck, thorax, pelvis, and abdomen, helping radiation therapy professionals by streamlining contouring tasks and integrating with treatment planning systems, though clinicians review and approve the results.

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, and Halcyon are integrated tools designed to help clinicians manage, plan, and deliver radiation therapy treatment. The software supports radiation therapy plan management and adaptive treatment planning, while the radiotherapy systems deliver precise radiation treatment using image guidance to treat lesions and tumors anywhere in the body. These tools aim to improve the accuracy and effectiveness of radiotherapy for patients, including adults and pediatric patients.