510(k) K063482

CROSSPLAN / ACCUSOFT-XL V.4.04 by Direx Systems Corp. — Product Code MUJ

K063482 is an FDA 510(k) premarket notification submitted by Direx Systems Corp. for the device "CROSSPLAN / ACCUSOFT-XL V.4.04". The FDA issued a decision of Substantially Equivalent on December 14, 2006. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Direx Systems Corp. has at least 10 other 510(k) clearances on record.