Device Dossier

Contrast medium injection system syringe

Device Dossier for Contrast medium injection system syringe (Contrast medium injection system syringe, Class IIa, sponsor Medical Sales & Radiology).…

Intended purpose

A sterile component of a contrast medium injection system for the administration of contrast media during CT (Intravenous), MRI (Intravenous), and Angiography (Intra-arterial) procedures. It is primarily an exchangeable piston-in-barrel chamber for the contrast medium; the movement of the piston is controlled by the contrast medium injector. The device includes check valves, spikes, and tubing.