FDA Radiology AI Devices

CoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.

TAIMedImg DeepMets is a software tool that uses artificial intelligence to assist medical professionals by automatically outlining brain metastases on MRI scans. This helps speed up the workflow for planning radiation therapy treatment in patients with diagnosed brain metastases, ensuring accurate contours that clinicians can verify and adjust as needed.

Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.

Second Opinion® 3D is an AI-powered software that helps dental professionals by automatically identifying and marking important anatomical structures in dental CBCT (Cone Beam Computed Tomography) radiographs. It highlights areas such as dentition, maxilla, mandible, and other key dental anatomical features, supporting clinicians to review images more efficiently and accurately. The software acts as a concurrent and second reader for patients aged 12 years or older, assisting in dental evaluation without replacing full clinical patient assessment.

Synapse 3D Base Tools (V7.0) is advanced medical imaging software from FUJIFILM designed to assist trained professionals in reading, interpreting, reporting, and planning treatment using images from various modalities such as CT, MRI, X-ray, ultrasound, and nuclear medicine. It provides powerful 3D viewing tools, image fusion, segmentation powered by deep learning, and supports multiple modalities and anatomical regions, which enhances diagnostic workflows and treatment planning for adult patients.

The Diagnostic Ultrasound System (including models Recho R9W, Recho R9, and others) by Shenzhen Mindray Bio-medical Electronics Co., Ltd. is a general-purpose, mobile ultrasound imaging system. It helps trained healthcare professionals acquire and display ultrasound images in multiple modes like B, M, Doppler, 3D/4D, elastography, and contrast imaging, aiding in the diagnosis and analysis of various body regions in adults, pediatric patients, pregnant women, and neonates.

Medical Image Post-processing Software (uOmnispace.CT) is sophisticated software designed to help radiologists and clinicians view, manipulate, evaluate, and analyze CT medical images. It includes multiple specialized processing applications for lungs, heart, brain, liver, bone structure, vascular structures, and more, helping clinicians quantify and characterize anatomical and functional information to support diagnosis and treatment planning.

Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.

LUMYS (V1) is a medical software platform designed to assist clinicians in pre-surgical planning by providing 3D visualization and interactive image segmentation of CT scan data. Using Microsoft HoloLens 2 for a mixed reality view, it enables surgeons and remote collaborators to annotate and interact with medical images in real time during procedures, improving communication and surgical precision, but it is not intended for primary diagnosis.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.