Device typeDiagnostic x-ray digital imaging system workstation: A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.
FDA categoryAngiographic Coronary Vascular Physiologic Simulation Software
Device ID17290017855087
Catalog numberFAU04000
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information