510(k) K250662

Bunkerhill MAC by BunkerHill Health — Product Code JAK

K250662 is an FDA 510(k) premarket notification submitted by BunkerHill Health for the device "Bunkerhill MAC". The FDA issued a decision of Substantially Equivalent on October 3, 2025. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. BunkerHill Health has at least 7 other 510(k) clearances on record.