Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding Class II Medical Device Functionality and PET-CT Capabilities

SAN FRANCISCO, Oct. 30, 2025 /PRNewswire/ -- Sirona Medical today announced that it 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). 

"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 a browser.

"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," said Ken Kaufman, Chief Executive Officer of Sirona Medical. "This is a foundational milestone for our customers."

Sirona's cloud-native architecture fundamentally changes how 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's Advanced Imaging Suite will begin rolling out to users as early as next week, with immediate availability for existing customers participating in early-access programs.

Sirona will host an exclusive webinar, "The Cloud-Native Path to Profitable Radiology," on November 5, 2025, at 1:00 PM ET. The session will feature Dr. Luke Roller and Dr. Jon Masur discussing how cloud-native architecture is transforming radiology practices. Attendees will learn how Sirona's RadOS™ platform helps eliminate workflow friction, simplify IT, and drive profitability by unifying PACS, reporting, and AI into a single cloud-native solution. To register, visit this link. Sirona will also be exhibiting at the Radiological Society of North America (RSNA) Annual Meeting (Booth 4569), where attendees can experience hands-on demonstrations of RadOS™ and learn more about how Sirona is redefining the modern radiology workflow.

About Sirona Medical
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.

For more information, visitwww.sironamedical.com.

SOURCE Sirona Medical