Encompass SRS Headframe ; Encompass MR SRS Headframe

Encompass SRS Headframe ; Encompass MR SRS Headframe is an FDA 510(k)-cleared medical device (K182189) manufactured by Qfix. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2018. Regulation: 8.