510(k) K242411

Brainomix 360 e-Lung by Brainomix Limited — Product Code JAK

K242411 is an FDA 510(k) premarket notification submitted by Brainomix Limited for the device "Brainomix 360 e-Lung". The FDA issued a decision of Substantially Equivalent on February 19, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Brainomix Limited has at least 10 other 510(k) clearances on record.