510(k) K261229

SCENARIA View Phase 6.0 by Fujifilm Corporation — Product Code JAK

K261229 is an FDA 510(k) premarket notification submitted by Fujifilm Corporation for the device "SCENARIA View Phase 6.0". The FDA issued a decision of Substantially Equivalent on September 18, 2026. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Fujifilm Corporation has at least 10 other 510(k) clearances on record.