510(k) K182639

MOBILETT Elara Max by Siemens Medi Cal Solutions, Inc. — Product Code IZL

K182639 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "MOBILETT Elara Max". The FDA issued a decision of Substantially Equivalent on March 15, 2019. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Siemens Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.