FDA Radiology AI Devices

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.

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.

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.

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.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.

The syngo Application Software is a medical imaging software developed by Siemens that enables real-time viewing, manipulation, 3D visualization, communication, and postprocessing of medical images. It supports diagnostic review and image-guided interventional procedures across multiple imaging modalities and clinical applications, improving workflow and aiding clinicians in diagnosis and treatment planning.

The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.