FDA Radiology AI Devices

This product consists of ultrasonic probes used in diagnostic imaging. These probes emit and receive ultrasound waves to create images of the body's internal structures, helping clinicians visualize and assess patients non-invasively.

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.

The Mendaera Guidance System is an ultrasonic diagnostic transducer designed to assist clinicians in medical imaging procedures by providing real-time ultrasound images. It helps healthcare providers visualize internal structures, aiding in diagnosis and treatment guidance.

The OPUSWAVE Dual Sensor Imaging System is a medical device that uses Optical Coherence Tomography to capture detailed images of cardiovascular structures. It helps clinicians by providing high-resolution imaging to assist in diagnosis and treatment of cardiovascular conditions.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.

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 uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.

MICSI-RMT is a software medical device designed to improve head MRI images by reducing noise, enhancing image quality to assist radiologists. It processes functional and diffusion MRI images without a user interface, outputting enhanced images for better visualization of brain structures and activation maps, aiding in clinical MRI interpretation.

SubtleSYNTH (1.x) is an AI-based software that synthesizes STIR contrast images from T1- and T2-weighted spine MRI sequences. It uses a convolutional neural network to generate synthetic images that can be reviewed alongside traditional MRI scans, helping radiologists by providing additional image contrast information without additional scanning time or patient burden.