FDA Radiology AI Devices

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

Hepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

The Aquilion Prime SP V10.2 with AiCE-i is an advanced CT imaging system that uses artificial intelligence through Deep Convolutional Neural Networks to reduce image noise and improve image clarity. This system helps clinicians capture better quality whole-body CT scans, including the head, optimizing image quality and potentially reducing radiation dose for patients.

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole-body multi-slice helical CT scanner. It captures high-quality cross-sectional volume images of whole organs in a single rotation. It includes advanced AI algorithms—AiCE for noise reduction using Deep Convolutional Neural Networks and FIRST iterative reconstruction to improve image quality and reduce radiation dose. It supports spectral imaging with rapid kV switching to differentiate material composition in tissues, aiding clinicians in diagnosis and treatment planning.

Auto Positioning is a feature for GE CT systems that streamlines and automates patient positioning for CT exams by using a 2D/3D video camera and AI (deep learning) to determine anatomical landmarks, patient orientation, and optimal table position. This helps technologists position patients accurately and safely, improving image quality and workflow efficiency.

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

Deep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.