510(k) K232022

CAS-One IR by Cascination AG — Product Code JAK

K232022 is an FDA 510(k) premarket notification submitted by Cascination AG for the device "CAS-One IR". The FDA issued a decision of Substantially Equivalent on March 13, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Cascination AG has at least 5 other 510(k) clearances on record.