510(k) K253026

Respiratory Gating for Scanners (2.1) by Varian Medical Systems, Inc. — Product Code JAK

K253026 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Respiratory Gating for Scanners (2.1)". The FDA issued a decision of Substantially Equivalent on June 4, 2026. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.