FDA Radiology AI Devices

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 CT/MR Tandem and Ovoid Set by Varian Medical Systems is a gynecological brachytherapy applicator that is used to treat cancers of the uterus, cervix, paracervix, endometrium, and vagina via HDR brachytherapy. The device is designed to be compatible with CT and MRI imaging, helping clinicians accurately deliver radioactive sources for cancer treatment. It improves patient care by ensuring precise radiation placement and is safe for MR environments.

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.

Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.

The Eclipse Treatment Planning System (version 18.1) is a software tool designed by Varian Medical Systems to assist clinicians in planning radiation therapy for patients with malignant or benign diseases. It uses medical imaging to create a virtual patient model to simulate and optimize radiation dose distributions for external beam and internal radiation treatments, ensuring effective tumor targeting while minimizing damage to healthy tissues. This system includes features for proton therapy and advanced optimization algorithms to enhance treatment quality and delivery efficiency.

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.