510(k) K082627

MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL by Minxray, Inc. — Product Code IZL

K082627 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL". The FDA issued a decision of Substantially Equivalent on Nov 7, 2008. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Minxray, Inc. has 17 other 510(k) clearances on record.