510(k) K101076

PROWESS PANTHER PROARC, MODEL VERSION 5.0 by Prowess, Inc. — Product Code MUJ

K101076 is an FDA 510(k) premarket notification submitted by Prowess, Inc. for the device "PROWESS PANTHER PROARC, MODEL VERSION 5.0". The FDA issued a decision of Substantially Equivalent on July 27, 2010. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Prowess, Inc. has at least 8 other 510(k) clearances on record.