510(k) K231574

Scenaria View 4.2 by FUJIFILM Healthcare Americas Corporation — Product Code JAK

K231574 is an FDA 510(k) premarket notification submitted by FUJIFILM Healthcare Americas Corporation for the device "Scenaria View 4.2". The FDA issued a decision of Substantially Equivalent on October 12, 2023. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. FUJIFILM Healthcare Americas Corporation has at least 10 other 510(k) clearances on record.