FDA Radiology AI Devices

The Biograph Vision.X and Biograph Vision.X Edge are advanced combined PET and CT scanners that provide high-resolution images by fusing metabolic and anatomical information. These systems assist healthcare professionals in detecting, diagnosing, and monitoring diseases such as cancer, cardiovascular and neurological disorders, and support treatment planning and interventional procedures.

AI-Rad Companion (Cardiovascular) is a software product that uses AI and deep learning to analyze previously acquired chest CT images, providing quantitative and qualitative assessments of cardiovascular structures like the heart and aorta. It helps clinicians by automating segmentation, volume measurement, calcium quantification in coronary arteries, and diameter measurements of the aorta, thus supporting accurate and efficient cardiovascular disease evaluation.

MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.

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.

AI-Rad Companion (Musculoskeletal) is an AI-powered software that analyzes previously acquired CT images to assist radiologists and physicians in evaluating musculoskeletal diseases. It segments, labels vertebrae, measures vertebral heights, and computes mean Hounsfield values to provide detailed quantitative and qualitative analysis, improving assessment and workflow efficiency for clinicians.

AI-Rad Companion Organs RT is a software product by Siemens that uses deep learning to automatically contour organs at risk on CT imaging data. The output contours help radiation oncologists plan external beam radiation therapy by providing accurate anatomical structures for treatment planning. The software processes CT scans, generates contour data in DICOM RTSTRUCT format, and integrates with treatment planning systems to improve clinician workflow and efficiency in radiation therapy preparation.

The MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit are MRI systems designed to produce detailed cross-sectional images and spectroscopic data of the head, body, and extremities. They support advanced imaging workflows and reconstruction frameworks, helping clinicians diagnose medical conditions by providing clear internal images and physical parameters. The system can also assist in interventional procedures with MR-compatible devices.

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.

syngo.CT Extended Functionality is a software package that provides advanced visualization and measurement tools for medical images acquired from CT and potentially other modalities like MRI. It helps technicians and physicians perform qualitative and quantitative analysis of clinical imaging data to assist in diagnosis by creating detailed images and measurements using various specialized extensions.