510(k) K220034

NEUROShield by In-Med Prognostics L3c — Product Code LLZ

K220034 is an FDA 510(k) premarket notification submitted by In-Med Prognostics L3c for the device "NEUROShield". The FDA issued a decision of Substantially Equivalent on September 14, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.