510(k) K250289

Intracavitary/Interstitial System by Varian Medical Systems — Product Code JAQ

K250289 is an FDA 510(k) premarket notification submitted by Varian Medical Systems for the device "Intracavitary/Interstitial System". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Medical Systems has at least 10 other 510(k) clearances on record.