510(k) K220582

ClearCalc Model RADCA V2 by Radformation, Inc. — Product Code MUJ

K220582 is an FDA 510(k) premarket notification submitted by Radformation, Inc. for the device "ClearCalc Model RADCA V2". The FDA issued a decision of Substantially Equivalent on August 22, 2022. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Radformation, Inc. has at least 10 other 510(k) clearances on record.