FDA Radiology AI Devices

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

The IODR1717 / IODR1417 / IODR1417-GF detectors are digital flat panel X-ray detectors designed for high-quality digital radiography in general anatomical imaging for adults and children. They replace film-based systems and facilitate faster, streamlined digital radiography with wireless or wired connectivity, enhancing image acquisition and processing for clinicians.

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.

VistaPano S Ceph 2.0 and related models are advanced 2-in-1 digital X-ray imaging systems designed to capture detailed panoramic and cephalometric images of the dento-maxillofacial region, sinus, and TMJ for adult and pediatric patients. It supports orthodontic treatment by also using carpal images. The systems are intended to be operated by medical professionals such as dentists, physicians, and x-ray technicians, improving diagnostic capabilities in dental and maxillofacial care.

The LCD Monitors C310S, G310S, C316S, G316S, and C616W by Shenzhen Beacon Display Technology Co.,Ltd. are high-resolution, calibrated diagnostic displays specifically designed for radiology. These monitors support the viewing and analysis of digital images such as X-rays and MRIs, helping clinicians review and diagnose patient conditions accurately. They incorporate advanced LED backlighting, brightness stabilization, and anti-glare screens to ensure image clarity and consistency, crucial for precise medical evaluation.

The ROCC Console is a software system that enables remote control, support, and standardization of medical imaging protocols, particularly for MR and CT scanners. It helps technologists and medical personnel operate scanners remotely and manage imaging protocols, improving workflow and access to expertise without requiring physical presence on site.

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.