510(k) K250766

LungQ 4 by Thirona BV — Product Code JAK

K250766 is an FDA 510(k) premarket notification submitted by Thirona BV for the device "LungQ 4". The FDA issued a decision of Substantially Equivalent on October 2, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Thirona BV has at least 1 other 510(k) clearance on record.