FDA Radiology AI Devices

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.

The SOMATOM go. Platform and SOMATOM X. Platform CT scanners, produced by Siemens Medical Solutions USA, Inc., are advanced computed tomography systems designed to generate detailed cross-sectional images of patients. These devices aid healthcare professionals in diagnosis, treatment planning, and radiation therapy across a variety of clinical scenarios, including lung cancer screening. The systems feature a fan-beam CT technology, sophisticated software for image reconstruction and optional AI-assisted workflow enhancements such as automated needle detection for intervention procedures, and innovative camera-based patient positioning workflows. They improve clinical accuracy and efficiency while ensuring patient comfort and safety.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed for producing high-quality cross-sectional images and spectroscopic images of the head, body, and extremities. It helps clinicians diagnose by providing detailed anatomical and functional images that can be interpreted by trained physicians. This device is designed to meet industry imaging standards and includes advanced components such as RF coils and gradient amplifiers to ensure high image quality.

MAGNETOM Terra and MAGNETOM Terra.X are advanced 7 Tesla MRI systems by Siemens designed for capturing high-quality magnetic resonance images primarily of the head and extremities. Equipped with enhanced hardware and AI-based software (Deep Resolve Boost, Sharp, and RxE), these devices improve image quality and reconstruction speed, helping radiologists obtain clearer diagnostic images faster, thus supporting better patient diagnosis and care.

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing lung diseases, improving workflow efficiency and diagnostic accuracy.

CINA-ASPECTS is a computer-aided diagnosis software designed to assist clinicians in evaluating brain tissue abnormalities using CT scans. It automatically analyzes regions of the brain affected by ischemic stroke, computes a standardized ASPECT score, and provides visual and quantitative data to support timely and accurate diagnosis of early acute stroke injury.

CINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.

The Voluson Signature 20 and Voluson Signature 18 are advanced diagnostic ultrasound systems designed primarily for general radiology and specialized OB/GYN use. They provide high-performance ultrasound imaging, including real-time 3D/4D acquisition and various Doppler imaging modes, to help clinicians visualize and analyze the human body and fluids. These systems support multiple clinical applications such as fetal imaging, abdominal, cardiac, vascular, musculoskeletal, and more, aiding in diagnosis and patient care in hospital or clinical settings.