FDA Radiology AI Devices

Contour ProtégéAI by MIM Software Inc. is a medical imaging software that assists trained medical professionals by automatically creating contours on CT and MR images using machine learning. It helps in radiation therapy by segmenting anatomical structures and specific tissues like the prostate and urethra from imaging data, improving efficiency and accuracy in treatment planning. The software works on multiple platforms and supports cloud or local deployment, allowing users to review and edit automated results for patient management and follow-up.

aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.

The Voluson Expert series (including models 22, 20, and 18) is a general-purpose ultrasound system designed for use by trained medical professionals. It supports a wide range of clinical applications including obstetrics/gynecology, abdominal, cardiac, pediatric, musculoskeletal, vascular, and more. The system offers multiple imaging modes such as B-mode, Doppler modes, 3D/4D imaging, elastography, and advanced AI features like SonoPelvicFloor2.0, SonoAVC2.0, Fibroid Mapping, Blood Speckle Imaging, and Ophthalmic Artery Measurement. These AI features assist clinicians by automating tasks such as organ and lesion segmentation, improving workflow efficiency and diagnostic confidence. It is intended for use in hospitals or clinics and complies with medical device safety standards.

MeVis Liver Suite is a medical image analysis software designed to assist physicians, especially radiologists and surgeons, in evaluating the liver and its vascular anatomy using CT and MR images. It provides tools for manual and AI-based semi-automatic segmentation of abdominal organs, liver lesions, and vascular structures, supporting treatment planning and follow-up assessment for liver-related conditions. The software calculates volumes, visualizes 3D vascular tumor margins, and enables manual spatial registration of images, enhancing clinical workflow without replacing diagnostic workstations.

The Philips Lumify Diagnostic Ultrasound System is a portable ultrasound device used by healthcare professionals to capture high-resolution ultrasound images and perform fluid flow analysis in various clinical applications including cardiac imaging. It incorporates an AI-based Auto EF Quantification feature that automatically assesses cardiac function by measuring the left ventricle’s ejection fraction, improving clinical workflows during cardiac examinations.

The Ultrasound System 1300 by BK Medical ApS is a mobile ultrasound system designed for diagnostic imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, neuro, musculoskeletal, and vascular imaging. It aids clinicians by providing advanced imaging modes and AI software features like Prostate Volume Assist for workflow improvement and accurate prostate volume measurements.

AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.

Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.

Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.