510(k) K221426

Functional MR V1.0 by Olea Medical S.A.S. — Product Code LLZ

K221426 is an FDA 510(k) premarket notification submitted by Olea Medical S.A.S. for the device "Functional MR V1.0". The FDA issued a decision of Substantially Equivalent on July 6, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Olea Medical S.A.S. has at least 10 other 510(k) clearances on record.