510(k) K212875

Spectral CT on Rails by Philips Medical Systems Nederland B.V. — Product Code JAK

K212875 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Spectral CT on Rails". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.