510(k) K220583

ClearCheck Model RADCC V2 by Radformation, Inc. — Product Code IYE

K220583 is an FDA 510(k) premarket notification submitted by Radformation, Inc. for the device "ClearCheck Model RADCC V2". The FDA issued a decision of Substantially Equivalent on August 23, 2022. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Radformation, Inc. has at least 10 other 510(k) clearances on record.