Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is an FDA 510(k)-cleared medical device (K182079) manufactured by Medtec Inc. Dba Civco Medical Solutions. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 6, 2018. Regulation: 8.