510(k) K251030

Sirona Advanced Imaging Suite by Sirona Medical — Product Code LLZ

K251030 is an FDA 510(k) premarket notification submitted by Sirona Medical for the device "Sirona Advanced Imaging Suite". The FDA issued a decision of Substantially Equivalent on Oct 22, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.