Device Dossier
CT contrast medium injection system, battery-powered
Device Dossier for CT contrast medium injection system, battery-powered (CT contrast medium injection system, battery-powered, Class IIb, sponsor Global…
- GMDN category: CT contrast medium injection system, battery-powered
- Sponsor: Global Medical Solutions
Intended purpose
The Iris is intended to prepare an accurate dose according the medical prescription, and to perform in bolo intravenous injection of radio-tracers for PET diagnostic procedure (Positron Emission Tomography), SPECT (Single Pho- ton Emission Computed Tomography) and radio-pharmaceuticals for therapy, permitting the protection of the medical personnel from the used radio-tracers or radio-pharmaceuticals. The Iris system is to be used exclusively in authorized environments in the hospital to the manipulation of radioisotope and to the execution of the PET and SPECT diagnosis.