Device Dossier
Workstation, nuclear medicine system
Device Dossier for Workstation, nuclear medicine system (Workstation, nuclear medicine system, Class IIb, sponsor Cyclomedica). ARTG record, intended…
- GMDN category: Workstation, nuclear medicine system
Intended purpose
Affinity displays, processes and analyzes nuclear medicine and radiology imaging data for investigation of physiological or pathological states. The functionality in Affinity is not intended to replace visual assessment by the intended user. Based on user input of injected activity, Affinity can calculate absorbed radiation dose and may guide the decision making for future selective internal radiation therapy (SIRT). The information obtained from the images, including quantitative analysis, may be used, in conjunction with other patient-related data, to inform clinical management.