FDA Radiology AI Devices

Contour ProtégéAI is a software tool that assists trained medical professionals by automatically creating contours on CT and MR medical images using machine-learning algorithms. It helps in quantitative analysis, adaptive therapy, image segmentation of various anatomical regions including prostate via MR images, and supports radiation therapy treatment planning. The contours can be reviewed and edited with appropriate visualization software.

VBrain-OAR is a software device from Vysioneer Inc. designed to assist trained radiotherapy personnel in brain tumor radiation therapy treatment planning by automatically generating contours of organs at risk in brain MRI images using AI deep learning. It also provides image registration functions to align multi-modality medical images. This device supports clinicians by providing initial contour outlines to improve the efficiency and consistency of radiation treatment planning, while still requiring final confirmation by qualified personnel.

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.

breastscape v1.0 is an advanced software tool used with Olea Sphere 3.0 to assist breast imaging physicians and MRI technologists in analyzing breast MRI data. It provides visualization, semi-automatic lesion segmentation, kinetic curve analysis, and planning assistance for MR-guided breast biopsy procedures, helping clinicians detect and characterize breast lesions and plan interventions more effectively.

The syngo.via RT Image Suite by Siemens is a software tool that helps clinicians visualize, manipulate, and contour medical images in 3D and 4D across multiple imaging modalities. It supports the preparation of radiation therapy treatments by allowing the viewing and editing of contours for tumors and organs-at-risk, managing points of interest, and generating synthetic CT images using AI algorithms. This tool improves the accuracy and efficiency of treatment planning for patients undergoing radiation therapy.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

aPROMISE is a cloud-based software platform that helps healthcare professionals and researchers manage, review, and analyze PSMA PET/CT medical images. It offers tools to mark and quantify regions of interest, supporting oncology care by providing quantitative analysis and report generation to inform patient management decisions.

The syngo.via MI WorkFlows, including Scenium and syngo MBF, is a software suite from Siemens designed to assist healthcare professionals by providing advanced image processing, visualization, and quantitative analysis for multiple medical imaging modalities such as PET, CT, MRI, and SPECT. It supports disease management in oncology, cardiology, neurology, and organ function, helping clinicians interpret complex images and plan treatments more effectively.

Automatic Anatomy Recognition (AAR) is a software medical device that uses deep learning to automatically identify and contour anatomical structures from CT scans. It is designed to assist technicians and physicians in radiation therapy planning by providing precise contours of organs at risk in the head, neck, and chest areas. This helps improve the accuracy and efficiency of treatment planning for patients undergoing radiation therapy for cancers in these body regions.

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.