FDA Radiology AI Devices

The Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. These systems support a variety of clinical applications, including fetal/obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organ imaging. They provide high-quality real-time imaging, including 3D/4D modes, and Doppler imaging types, aiding clinicians in the diagnosis and monitoring of patients in hospital or clinical settings.

The SIGNA Artist Evo is a whole-body magnetic resonance imaging (MRI) scanner designed to provide high resolution and high signal-to-noise ratio images with short scan times. It supports imaging multiple body regions such as the head, spine, heart, abdomen, pelvis, and musculoskeletal systems. The images produced help clinicians diagnose a wide range of medical conditions based on molecular and anatomical information from MRI signals.

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.

The Micro C Medical Imaging System, M01 by OXOS Medical, Inc. is a handheld, portable mobile X-ray device intended for use by trained clinicians to capture diagnostic images of extremities. It features an AI-based software called AiLARA that recommends power settings and exposure times to optimize image quality and reduce retakes, enhancing clinician efficiency and patient safety.

The Revolution Ascend is a CT scanner designed to generate detailed cross-sectional images of various body parts including the head, whole body, cardiac, and vascular areas. It uses x-ray transmission data taken at different angles and planes. The device supports multiple acquisition modes and post-processing of images, aiding clinicians in diagnosing disease, trauma, and abnormalities, as well as planning and monitoring therapy.

Contour ProtégéAI by MIM Software Inc. is an AI-powered software tool that helps trained medical professionals automatically create contours of anatomical structures on CT and MRI scans. The software uses machine-learning algorithms to segment normal organs and tissues, aiding in quantitative analysis and radiation therapy planning. It is intended to improve workflow efficiency and treatment accuracy by automating tedious contouring tasks.

syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

syngo.CT Extended Functionality is a software suite from Siemens that provides advanced visualization tools for CT and possibly MRI medical images. It helps technicians and physicians perform qualitative and quantitative measurements, facilitates advanced clinical evaluations using various extensions, and supports processing to aid in diagnosis.

SIGNA Hero is a whole body 3.0 Tesla MRI scanner from GE Healthcare that supports high resolution images with a high signal-to-noise ratio and short scan times. It produces detailed images of structures and functions throughout the body to aid physicians in diagnosis by providing axial, sagittal, coronal and oblique images, along with spectroscopic and dynamic imaging capabilities.