FDA Radiology AI Devices

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

MI View&GO by Siemens Medical Solutions USA, Inc. is medical diagnostic software designed to assist healthcare professionals in viewing and analyzing medical images from multiple modalities including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy treatment planning by providing users with tools for image manipulation, quantification, and comparison at or near the scanner console, enhancing workflow efficiency and diagnostic accuracy.

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.

Rapid (6.0) by iSchemaView, Inc. is a medical imaging software designed to process and analyze dynamic and functional imaging data from CT and MRI scans. It aids clinicians by providing advanced visualization, quantification, and analysis tools to help select acute stroke patients for treatment, enhancing diagnostic confidence and workflow efficiency.

Syngo Carbon Clinicals is a software package that provides advanced visualization tools to help healthcare professionals prepare, measure, and analyze medical images from modalities such as CT and MRI. It supports manipulation and communication of clinical data, enabling qualitative and quantitative assessment to assist in diagnosis and treatment planning.

syngo.via MI Workflows, including Scenium and syngo MBF, is software that helps healthcare professionals analyze medical images from multiple modalities such as PET, SPECT, CT, and MR. It aids disease management in oncology, cardiology, neurology, and organ function by providing tools for image viewing, quantification, comparison, and radiotherapy planning. The software integrates advanced AI algorithms for automating organ segmentation and supports new workflows such as tau quantification in brain imaging, thus improving diagnostic and treatment planning efficiency.

aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.

uOmnispace is a medical image post-processing software solution that supports viewing, manipulation, annotation, and communication of various medical images from multiple modalities including CT, MRI, PET and DR. It includes AI-based segmentation tools like rib segmentation, and enables remote multi-user access and integration with medical imaging systems. It helps clinicians efficiently analyze and report on diagnostic images.

Brainlab Elements is a suite of software applications that process and analyze medical image data from various modalities to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration (fusion), segmentation (contouring), diffusion tensor imaging (fibertracking), blood oxygen level dependent MRI analysis (BOLD MRI mapping), and cerebrovascular image fusion (Image Fusion Angio). These capabilities help improve precision and understanding of patient anatomy and function during clinical procedures.

Ceevra Reveal 3 is a software medical device designed for processing, reviewing, and analyzing 3D images created from CT and MR scans. It helps clinicians with preoperative surgical planning and intraoperative image display, including interacting with 3D visualizations using mobile or desktop viewers, and even VR headsets. By using AI-driven algorithms, it generates preliminary segmentations of normal anatomical structures to assist healthcare professionals in their clinical decisions for adult patients.