510(k) K223447

OmniTom Elite by Neurologica Corporation, A Subsidiary of Samsung — Product Code JAK

K223447 is an FDA 510(k) premarket notification submitted by Neurologica Corporation, A Subsidiary of Samsung for the device "OmniTom Elite". The FDA issued a decision of Substantially Equivalent on June 1, 2023. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neurologica Corporation, A Subsidiary of Samsung has at least 1 other 510(k) clearance on record.