FDA Radiology AI Devices

The SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a CT X-ray system that produces cross-sectional images of the body, particularly the cardiovascular and thoracic regions. It includes protocols for low dose CT scans aimed at lung cancer screening, ensuring minimal radiation exposure while maintaining image quality. This device assists clinicians in diagnosing lung cancer and planning related therapies, utilizing advanced image reconstruction algorithms and adaptable scan techniques for patients of various sizes.

DeepFoqus-Accelerate is an AI-driven software solution designed to improve brain MRI scans by reconstructing accelerated MRI data up to 4 times faster, producing clinical-quality images from undersampled data. It helps radiologists and technologists by enhancing non-contrast brain MRI images from 1.5T or 3T Siemens and GE scanners, making MRI scanning more efficient while maintaining image quality.

RayStation and RayPlan are advanced software systems designed for radiation therapy planning and medical oncology. They help clinicians propose and optimize treatment plans based on patient imaging data, improving the delivery of safe and effective radiation doses. The software supports a range of radiotherapy techniques, including photon and proton therapies, and incorporates sophisticated dose calculation and optimization algorithms to tailor treatments to individual patients' needs.

The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

Green X 21 (PHT-90CHO) is an advanced 6-in-1 digital dental X-ray system that combines multiple imaging modalities including panoramic, cephalometric, and 3D CT scans for diagnostic details of dento-maxillofacial, sinus, TMJ, and ENT regions. It helps clinicians by providing comprehensive imaging from one device to improve diagnosis and treatment planning, especially for adult and pediatric dental and ENT patients.

SureWave Elastography is an accessory device for Siemens MRI systems that generates shear wave vibrations during MRI scans to create images showing tissue stiffness. This advanced imaging helps physicians diagnose tissue abnormalities by providing detailed stiffness maps alongside traditional MRI images.

The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

The SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option is a computed tomography (CT) X-ray system developed by Arineta Ltd. It produces detailed cross-sectional images of the body, especially of the cardiovascular and thoracic areas, enabling clinicians to screen and diagnose lung cancer using low-dose CT protocols. This device helps physicians detect lung nodules and other thoracic abnormalities with reduced radiation exposure, supporting effective lung cancer screening programs following clinical guidelines.