FDA Radiology AI Devices

The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.

True Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.

The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.

Preview Shoulder is a software tool designed to help orthopedic surgeons plan shoulder surgery using 3D models created from CT scans. It allows surgeons to place digital implants within the shoulder anatomy and generate detailed surgical plans to improve surgical outcomes. This software is used as a pre-operative planning aid and is intended for adult patients only, not for diagnostic purposes.

AI-Rad Companion Organs RT is an AI-powered medical imaging software designed to automatically segment organs from CT and MR scans to assist radiation therapy treatment planning. It uses deep learning algorithms to produce contours of organs-at-risk, which clinicians can review and edit before using them in treatment planning systems. This software saves time and improves the accuracy of radiation therapy preparation by providing automated organ delineation, intended for use by trained medical professionals.

The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is a multi-slice CT scanner that uses advanced AI-based deep learning reconstruction algorithms to improve image quality by enhancing spatial resolution and reducing noise. It can capture detailed cross-sectional volumes of the whole body including organs like the brain, heart, and pancreas in a single rotation, assisting physicians in diagnostic and specialized studies.

Us2.v2 is software that processes cardiac ultrasound images to automatically measure various heart structures and functions, helping clinicians analyze echocardiograms more efficiently and accurately. It supports qualified healthcare professionals by providing automated measurements of cardiac size and function, improving workflow and aiding diagnosis in adult patients.

AVIEW CAC is a software that analyzes non-contrast chest CT scans to quantify calcified plaques in coronary arteries, calculate the Agatston score, and provide risk stratification based on calcium scoring, age, and gender. It helps radiologists and cardiologists by supporting image storage, transfer, and display, facilitating clinical decision-making for coronary artery disease risk assessment.

The NAEOTOM Alpha is a dual-source computed tomography (CT) scanner developed by Siemens Medical Solutions. It uses advanced photon-counting detector technology and incorporates AI-driven image reconstruction and post-processing software to produce highly detailed cross-sectional images. This device assists trained clinicians in diagnosing and treating patients, including applications like low-dose lung cancer screening in high-risk populations. It features enhanced workflow tools, integrated needle guidance for interventions, and supports sophisticated quantitative imaging techniques.