Sirona Advanced Imaging Suite Gets FDA 510(k) Clearance

Oct. 30, 2025 — Sirona Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking a significant regulatory milestone and the company's first Class II medical device designation. This clearance expands Sirona's diagnostic imaging capabilities to include PET-CT support with quantitative SUV analysis, image fusion, maximum intensity projection (MIP) generation and multi-planar reconstruction (MPR).