510(k) K171353

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris by Minxray, Inc. — Product Code IZL

K171353 is an FDA 510(k) premarket notification submitted by Minxray, Inc. for the device "CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris". The FDA issued a decision of Substantially Equivalent on Jun 7, 2017. 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.