FDA Radiology AI Devices

RayStation 12A by RaySearch Laboratories is a comprehensive radiation therapy treatment planning system that allows users to import patient images, define treatment targets, optimize and evaluate radiation treatment plans, and administer them. It supports multiple imaging modalities including CT, PET, and MR, enhancing precision in oncologic care by helping clinicians design effective and tailored radiation treatments while ensuring safety and accuracy.

The Xeleris V Processing and Review System by GE Healthcare is a software platform designed for processing, reviewing, and analyzing nuclear medicine and PET imaging data. It supports various clinical applications including brain, lung, cardiac, liver, and bone imaging analyses, aiding physicians in diagnosis and treatment planning by providing enhanced image visualization, quantification, and monitoring of patient radiation doses.

Oncospace is a software tool that assists radiation oncologists and medical dosimetrists in planning radiotherapy treatments for patients with cancer in the prostate, head, and neck regions. It uses locked machine learning algorithms to predict achievable dose objectives for organs at risk based on the patient's anatomy and automates aspects of treatment plan optimization. This helps clinicians customize treatment protocols, optimize radiation dose delivery while sparing healthy tissue, and review treatment plans efficiently, ultimately supporting better patient care in radiation oncology.

AIBOLIT 3D+ is a web-based software system that processes CT and MR medical images to create detailed 2D and 3D visualizations of anatomical structures. It assists healthcare professionals in surgical planning, training, and intraoperative reference by turning multi-dimensional images into easy-to-view and manipulate anatomical models, with color-coded organ identification to improve clinical decision-making.

Syngo Dynamics (Version VA40F) is a software medical device from Siemens designed to assist healthcare professionals in reviewing and analyzing medical images for disease detection and patient management. It supports multiple imaging modalities including ultrasound, x-ray angiography, CT, MR, nuclear medicine, and others, with applications primarily focused on cardiology, vascular, and fetal imaging. The software offers advanced image processing tools and semi-automated measurement capabilities such as left ventricular ejection fraction estimation, helping clinicians interpret complex imaging data efficiently within healthcare networks.

The syngo.via RT Image Suite by Siemens is advanced software that helps clinicians visualize and manipulate 3D and 4D medical images from multiple modalities like CT, MRI, PET, and CBCT. It supports contouring tumors and organs at risk, image registration, and creating simple treatment plans, aiding radiation therapy preparation. The software includes AI-based deep learning for lung lobe segmentation to calculate lung ventilation, improving the accuracy and efficiency of radiation therapy planning.

MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.

ART-Plan is an advanced software tool designed to assist medical professionals in cancer radiotherapy planning. It supports visualization and manipulation of 3D multi-modal medical images (CT, MR, PET-CT, CBCT, 4D-CT) and includes AI-driven automatic and semi-automatic segmentation of organs at risk and lymph nodes. It also allows image registration and generation of synthetic CT images from MRI, facilitating precise and efficient radiation treatment planning.

Segment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.

Rapid is a medical image processing software that helps clinicians visualize and analyze tissue changes in CT and MRI images, particularly aiding in the selection of acute stroke patients for treatment. It uses AI/ML components to detect image artifacts and supports advanced imaging features such as perfusion, diffusion and dynamic contrast analysis.