Kelowna GYN and Crook Prostate Templates

Kelowna GYN and Crook Prostate Templates is an FDA 510(k)-cleared medical device (K162533) manufactured by Varian Medical Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2017. Regulation: 8.