510(k) K030666

MULTICARE PLATINUM SYSTEM AND ACCESSORIES by Lorad, A Hologic Co. — Product Code IZH

K030666 is an FDA 510(k) premarket notification submitted by Lorad, A Hologic Co. for the device "MULTICARE PLATINUM SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 25, 2003. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Lorad, A Hologic Co. has at least 4 other 510(k) clearances on record.