510(k) K243209

nordicMEDiVA by Nordicneurolab AS — Product Code LLZ

K243209 is an FDA 510(k) premarket notification submitted by Nordicneurolab AS for the device "nordicMEDiVA". The FDA issued a decision of Substantially Equivalent on October 22, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Nordicneurolab AS has at least 10 other 510(k) clearances on record.