510(k) K250928

OmniTom Elite with PCD by Neurologica Corporation — Product Code JAK

K250928 is an FDA 510(k) premarket notification submitted by Neurologica Corporation for the device "OmniTom Elite with PCD". The FDA issued a decision of Substantially Equivalent on September 8, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neurologica Corporation has at least 7 other 510(k) clearances on record.