FDA Radiology AI Devices

THINQ is a medical imaging software device designed to automatically segment, label, and measure volumes of brain structures from 3D T1-weighted MRI scans. It provides clinicians with visual and quantitative reports comparing brain volumes to reference data, helping in the assessment of neurological conditions by automating brain morphometry.

Xeleris V Processing and Review System is a nuclear medicine software platform that helps physicians process, review, and quantify medical images from nuclear medicine, PET, and associated CT or MR scans. It supports multiple clinical applications including detection of brain diseases, lung conditions, coronary artery disease, and bone metastases, using AI-based image analysis such as deep learning for automated segmentation to enhance workflow efficiency and accuracy.

AVA (Augmented Vascular Analysis) by See-Mode Technologies is a software that uses artificial intelligence to analyze vascular ultrasound images from carotid and lower limb arteries. It segments vessel walls, measures carotid intima-media thickness, reads Doppler velocities, and generates detailed vascular ultrasound reports to aid clinicians like physicians and medical technicians in assessing cardiovascular health. The software runs on standard computers or cloud platforms and supports quality control by qualified clinicians to ensure accuracy.

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.

Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.

VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.

AI-Rad Companion Prostate MR is AI-powered image analysis software designed to assist radiologists in viewing, segmenting, and analyzing prostate MR images to support targeted MR-US fusion biopsies. It automates prostate gland segmentation, allows manual annotation of findings, calculates PSA density, and exports results for biopsy planning, improving workflow and biopsy accuracy for clinicians.

Contour ProtégéAI is a software tool designed to assist medical professionals by automatically creating anatomical contours on CT and MR medical images using machine learning. It supports applications such as adaptive therapy, radiation treatment planning, and management of patient images. The software requires manual review and editing of contours to ensure accuracy, improving clinical workflow efficiency and patient care.

LVivo Software Application is an AI-powered ultrasound image analysis platform that automatically calculates important medical parameters related to cardiac and bladder function. It helps clinicians assess heart ventricles and bladder volume using processed ultrasound images, thereby improving diagnostic efficiency and accuracy.