FDA Radiology AI Devices

The EXSYS DEXi is a stationary X-ray system designed for generating radiographic images of human anatomy for general diagnostic purposes. It functions by acquiring images through radiation exposure and processing these images at a workstation to provide anatomical information. This system supports clinicians in diagnosing a wide range of conditions by delivering high-quality digital radiographs, and it is not intended for mammography.

nordicMEDiVA is an advanced software platform designed to analyze and visualize functional and dynamic MRI data of the brain. It automates image processing pipelines and provides clinicians with derived imaging parameters through a web-browser interface, facilitating the evaluation of brain function and structure to aid clinical decision-making.

The ARTIS icono (VE40A) family and ARTIS pheno (VE40A) are advanced angiography systems that enable detailed imaging for diagnostic and interventional procedures. They support single-plane and biplane imaging with a motorized C-arm and flat panel detector, allowing clinicians to perform cardiac, neuro, general angiography, and image-guided surgeries. The systems provide 2D and 3D imaging capabilities, including 3D reconstruction software (DynaCT), which helps clinicians visualize both hard and soft tissues for diagnosis, surgical planning, and treatment follow-up.

Contour+ (MVision AI Segmentation) is a software tool that uses machine learning algorithms to automatically create contour outlines of anatomical regions on CT and MRI scans. It assists clinicians in radiation therapy planning by providing initial segmentations of organs and tissues, which professionals can review and modify before treatment planning. This speeds up the workflow and improves efficiency in radiation treatment preparation.

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.

The dS Knee Coil 8ch 1.5T is an 8-channel phased array MRI coil designed for use with Philips 1.5T MRI systems to produce high-resolution diagnostic images of the knee. The coil's design improves signal-to-noise ratio and patient comfort, enabling accurate imaging of knee anatomy for clinical evaluation by trained physicians.

The dS Wrist Coil 8ch 1.5T is a specialized MRI coil designed to produce high-quality diagnostic images of the wrist. It improves image clarity by using an 8-channel phased-array design for better signal reception, helping physicians accurately evaluate wrist conditions through MRI scans.

The Spectral CT 7500 RT is an advanced computed tomography (CT) system that uses dual-layer detector technology to acquire high and low energy X-ray data simultaneously. This allows it to generate detailed cross-sectional images and analyze the chemical composition of tissues and contrast agents. It supports applications in radiology, cardiology, oncology, and radiation therapy planning, helping clinicians visualize and assess anatomical and pathological structures more accurately.

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

JLK-CTP is an image processing software that helps trained medical professionals analyze brain CT perfusion images. It automatically receives, processes, and visualizes dynamic CT perfusion datasets to calculate blood flow and volume parameters, aiding in the assessment of cerebral blood flow and tissue status in brain imaging.