510(k) K232392

CT Lung Ventilation Analysis Software (CT:V) by 4Dmedical Limited — Product Code JAK

K232392 is an FDA 510(k) premarket notification submitted by 4Dmedical Limited for the device "CT Lung Ventilation Analysis Software (CT:V)". The FDA issued a decision of Substantially Equivalent on Nov 16, 2023. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. 4Dmedical Limited has at least 1 other 510(k) clearance on record.