Device Dossier
Infusion pump, general-purpose
Device Dossier for Infusion pump, general-purpose (Infusion pump, general-purpose, Class IIb, sponsor Imaxeon). ARTG record, intended purpose, GMDN…
- GMDN category: Infusion pump, general-purpose
Intended purpose
The Radiopharmaceutical Infusion System is intended to deliver accurate doses of radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The Infusion System is also intended to provide effective radiation shielding to medical personnel from radiation exposure during nuclear medicine diagnostic procedures