510(k) K000922

PROTON VISION by Varian Assoc., Inc. — Product Code MUJ

K000922 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "PROTON VISION". The FDA issued a decision of Substantially Equivalent on May 24, 2000. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.