510(k) K200435

Catalyst+, Catalyst+ HD by C-Rad Positioning AB — Product Code IYE

K200435 is an FDA 510(k) premarket notification submitted by C-Rad Positioning AB for the device "Catalyst+, Catalyst+ HD". The FDA issued a decision of Substantially Equivalent on May 7, 2020. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. C-Rad Positioning AB has at least 5 other 510(k) clearances on record.