Device Dossier
SPECT/CT diagnostic imaging system
Device Dossier for SPECT/CT diagnostic imaging system (SPECT/CT diagnostic imaging system, Class IIb, sponsor GE Healthcare). ARTG record, intended…
- GMDN category: SPECT/CT diagnostic imaging system
- Sponsor: GE Healthcare
Intended purpose
The system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using tomographic scanning mode supported by various acquisition types, and a Computed Tomography system which is intended for enabling CT-based correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.