510(k) K250648

Philips iCT CT system by Philips Medical Systems Nederland B.V. — Product Code JAK

K250648 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Philips iCT CT system". The FDA issued a decision of Substantially Equivalent on June 27, 2025. 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 at least 10 other 510(k) clearances on record.