510(k) K071717

GE OEC ALTITUDE by Shimadzu Corp. — Product Code IZI

K071717 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "GE OEC ALTITUDE". The FDA issued a decision of Substantially Equivalent on July 5, 2007. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Shimadzu Corp. has at least 10 other 510(k) clearances on record.