510(k) K182079

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask by Medtec Inc. Dba Civco Medical Solutions — Product Code IYE

K182079 is an FDA 510(k) premarket notification submitted by Medtec Inc. Dba Civco Medical Solutions for the device "Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medtec Inc. Dba Civco Medical Solutions has at least 1 other 510(k) clearance on record.