The US Food and Drug Administration (FDA) has granted 510(k) clearance to Sirona Medical’s Advanced Imaging Suite.

This move marks the company’s inaugural receipt of Class II medical device status.

The latest clearance broadens the company’s diagnostic imaging scope to include positron emission tomography-computed tomography (PET-CT) support with quantitative standardised uptake value (SUV) analysis, generation of maximum intensity projection (MIP), image fusion, and multi-planar reconstruction (MPR).