FDA Radiology AI Devices

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.

SMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.

Syngo Carbon Enterprise Access (VA40A) is a software-only medical device developed by Siemens Healthcare GmbH for use in healthcare institutions. It provides an enterprise-wide web application to display and render DICOM and non-DICOM medical data, supporting image and result distribution for diagnostic use by trained medical professionals. The software facilitates standardized data access without controlling image acquisition and enhances clinical workflows with a user-friendly interface. It does not include automated diagnostic functions but supports quality display and management of medical images and documents.

YSIO X.pree is a digital stationary X-ray system designed to create X-ray images of various body parts including the skull, chest, abdomen, and extremities. It helps medical professionals visualize anatomical structures to support diagnosis and treatment. The system features updated software, new wireless detectors, and AI-based functions like auto-cropping and automatic collimation to improve image quality and ease of use.

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.