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

Sirona Medical received FDA 510(k) clearance on April 3, 2025, for its Advanced Imaging Suite, designated under 21 CFR 892.2050 as a Medical Image Management and Processing System (Class II)45.

The suite is specifically noted for expanding radiological imaging technology functionality, particularly enhancing PET-CT imaging capabilities53.

This clearance allows Sirona Medical to market their device in the US, confirming its substantial equivalence to legally marketed predicate devices for medical image management applications43.

The Advanced Imaging Suite combines enhanced imaging workflow management, safety controls, and advanced diagnostic imaging features within a regulated Class II device framework35.

Sources:

3. https://www.diagnosticimaging.com/view/sirona-medical-gets-fda-nod-for-advanced-imaging-suite

4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251030

5. https://www.bioworld.com/articles/725454-regulatory-actions-for-oct-30-2025