510(k) K203172

MOSAIQ Oncology Information System by Elekta Solutions AB — Product Code IYE

K203172 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "MOSAIQ Oncology Information System". The FDA issued a decision of Substantially Equivalent on December 18, 2020. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Elekta Solutions AB has at least 10 other 510(k) clearances on record.