510(k) K042840

SHIMADZU COLLIMATOR R-20J by Shimadzu Corp. — Product Code IZX

K042840 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU COLLIMATOR R-20J". The FDA issued a decision of Substantially Equivalent on December 3, 2004. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Shimadzu Corp. has at least 10 other 510(k) clearances on record.