510(k) K162533

Kelowna GYN and Crook Prostate Templates by Varian Medical Systems, Inc. — Product Code JAQ

K162533 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "Kelowna GYN and Crook Prostate Templates". The FDA issued a decision of Substantially Equivalent on Aug 31, 2017. 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, Inc. has 205 other 510(k) clearances on record.