Sirona Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the Sirona Advanced Imaging Suite. The regulatory action marks the company’s first Class II medical device designation.

The 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). 

“This milestone reflects our commitment to closing the most critical capability gaps that limit the flexibility and reach of modern radiology,” said Dr. Peter Sachs, radiologist, imaging informaticist, and Sirona advisor. “By pioneering the field of 100% cloud-native PET viewing and PET-CT fusion, we’re enabling radiologists to interpret advanced imaging studies from anywhere—without compromise in diagnostic confidence, speed, or quality.”

The clearance follows an extensive multi-disciplinary effort across Sirona’s product, engineering, quality, and regulatory teams. The newly-cleared functionality represents a significant step in Sirona’s mission to unify the radiology workflow by bringing advanced visualization, reporting, and collaboration into a single, cloud-native environment accessible through the browser, according to the company.

“With PET/CT now cleared, Sirona has completed a four-year journey toward delivering the most complete, FDA-cleared, and cloud native diagnostic environment in the industry,” Sirona Medical CEO Ken Kaufman stated. “This is a foundational milestone for our customers.”

Sirona’s cloud-native architecture fundamentally changes the way innovation reaches radiologists. With the FDA clearance of the Sirona Advanced Imaging Suite, new functionality no longer requires complex, site-by-site installations or lengthy upgrade cycles. Instead, capabilities can be deployed to every user instantly through the cloud.

Sirona Medical is a San Francisco–based healthcare technology company unifying radiology IT applications—worklist, viewer, reporter, archive, and AI—into a single, cloud-native workspace. Built on its RadOS operating system, Sirona enables radiologists to work as fast as they can think through unified, intelligent workflows that connect imaging, data, and reporting in real time.