510(k) K945400

HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 by Hitachi Medical Corp. of America — Product Code IZI

K945400 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100". The FDA issued a decision of Substantially Equivalent on November 20, 1995. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.