Device Dossier
X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital
Device Dossier for X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital (X-ray system, diagnostic, fluoroscopic, angiographic,…
Intended purpose
Integrated imaging system consisting of a family of x-ray angiography and magnetic resonance imaging subsystems, intended for interventional, diagnostic and intra-operative imaging. The system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventional procedures. The system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use.