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AMRAD Medical
This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.
Details
Device typeMobile general-purpose fluoroscopic x-ray system, digital: A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.
FDA categoryImage-Intensified Fluoroscopic X-Ray System, Mobile, Interventional Fluoroscopic X-Ray System
Device ID08055186670396
Catalog number74 09 000-1
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information