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 announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking 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.

“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.

The clearance followed extensive work across Sirona’s product, engineering, quality, and regulatory teams. The newly cleared functionality brings advanced visualization, reporting, and collaboration into a single cloud-native environment accessible through a browser.

Sirona’s cloud-native architecture enables new functionality deployment to all users instantly through the cloud rather than requiring site-by-site installations.

The Advanced Imaging Suite rollout begins the following week, with immediate availability for existing early-access customers.

Sirona will host a webinar November 5, 2025, at 1:00 PM ET titled “The Cloud-Native Path to Profitable Radiology” featuring Dr. Luke Roller and Dr. Jon Masur. Sirona will exhibit at the Radiological Society of North America (RSNA) Annual Meeting (Booth 4569).

About Sirona Medical Inc.

Sirona Medical Inc. is addressing the needs of today’s radiology practices with a novel cloud-native platform that unifies radiology IT applications — worklist, viewer, reporter, archive, and AI — into a single, streamlined workspace. Sirona’s radiology operating system (RadOS) represents the first-of-its-kind rearchitecting of an enterprise imaging IT infrastructure. It puts radiologists in the driver’s seat with novel AI-powered solutions that simplify their workflow and amplify their work product. Based in San Francisco, CA, Sirona Medical is founded on a deep understanding of both the practice and business of radiology, to enable radiologists to work as fast as they can think. To learn more about how Sirona Medical can enhance your radiology practice, visit www.sironamedical.com.

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