FDA Radiology AI Devices

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.

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.

The Revolution Ascend Sliding is a CT X-ray system designed to generate detailed cross-sectional images of the body, including head, whole body, cardiac, and vascular areas. Uniquely, it features a gantry mounted on a transporter allowing linear movement on rails, improving patient workflow by enabling imaging and treatment procedures in the same room without moving the patient. It supports a range of acquisition modes and image processing features to aid clinicians in diagnosis and therapy monitoring.

HealthFLD is an AI-powered software that analyzes CT images of the liver to provide clinicians with quantitative and qualitative measurements of liver attenuation, aiding the assessment of fatty liver disease. It processes both non-contrast and contrast CT scans for adult patients and outputs liver density metrics to support clinical decision-making.

LungQ v3.0.0 is a software tool that helps physicians analyze CT scans of the lungs by automatically segmenting lung structures, measuring lung volumes and densities, evaluating fissures, and generating reports. It supports diagnosis and monitoring of lung conditions by providing quantitative assessments from CT scans, streamlining clinical workflows.

The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.

BriefCase-Quantification by Aidoc Medical is an AI-driven software designed to analyze non-cardiac-gated, non-contrast CT scans including the heart to detect and categorize coronary artery calcification (CAC). It provides physicians with a four-category risk assessment for coronary artery disease along with preview images of detected calcium, assisting clinical evaluation but not replacing full image review or clinical judgement.

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.

SpotLight/SpotLight Duo (with DLIR option) is a CT scanner that produces cross-sectional images of the body, including cardiovascular and thoracic anatomies. It uses a dual-tube CT system and advanced deep learning reconstruction to enhance image quality while reducing noise. This helps clinicians obtain clearer diagnostic images for disease detection and therapy planning.

The NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems is a CT scanner designed for whole body imaging, producing cross-sectional images to help clinicians diagnose various medical conditions. It incorporates advanced AI-powered reconstruction methods to reduce noise and enhance image quality, potentially lowering radiation dose for patients while improving diagnostic capabilities.