510(k) K223532

Olea S.I.A. Neurovascular V1.0 by Olea Medical — Product Code LLZ

K223532 is an FDA 510(k) premarket notification submitted by Olea Medical for the device "Olea S.I.A. Neurovascular V1.0". The FDA issued a decision of Substantially Equivalent on June 6, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Olea Medical has at least 10 other 510(k) clearances on record.