510(k) K040870

SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS by Shimadzu Corp. — Product Code JAA

K040870 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS". The FDA issued a decision of Substantially Equivalent on May 17, 2004. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Shimadzu Corp. has at least 10 other 510(k) clearances on record.