510(k) K884598

SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 by Shimadzu Precision Instruments, Inc. — Product Code JAA

K884598 is an FDA 510(k) premarket notification submitted by Shimadzu Precision Instruments, Inc. for the device "SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200". The FDA issued a decision of Substantially Equivalent on April 20, 1989. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Shimadzu Precision Instruments, Inc. has at least 10 other 510(k) clearances on record.