510(k) K211711

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

K211711 is an FDA 510(k) premarket notification submitted by Neurologica Corporation, A Subsidiary Of Samsung Electronics for the device "OmniTom Elite". The FDA issued a decision of Substantially Equivalent on Feb 25, 2022. 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 Electronics has 3 other 510(k) clearances on record.