510(k) K231047

UniSyn Molecular Imaging (6-3-1) by Convergent Imaging Solutions — Product Code LLZ

K231047 is an FDA 510(k) premarket notification submitted by Convergent Imaging Solutions for the device "UniSyn Molecular Imaging (6-3-1)". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Convergent Imaging Solutions has at least 1 other 510(k) clearance on record.