FDA gives 510(k) approval to Discovery IQ PET/CT System for Imaging-GE HealthCare
The FDA has given 510(k) clearance of the Discovery IQ PET/CT system, from GE HealthCare, for Imaging. Discovery IQ delivers amongst the highest NEMA (National Electrical Manufacturers Association) sensitivity (up to 22 cps/kBq) and the largest axial field-of-view (up to 26 cm) of PET/CT equipment on the market and can image with both half the PET dose and half the scan time.
It uses the NEW GE LightBurst PET detector technology designed to deliver high sensitivity. This provides up to 26 cm of coverage which enables scanning in the fewest possible bed positions. Full organ coverage at fast acquisition times; e.g., thorax respiratory motion correction coverage as fast as 4 minutes. Finally it is optimized for oncology practices administering 18F as done in 94% of procedures.