510(k) K181279

Ysio Max by Siemens Medi Cal Solutions, Inc. — Product Code KPR

K181279 is an FDA 510(k) premarket notification submitted by Siemens Medi Cal Solutions, Inc. for the device "Ysio Max". The FDA issued a decision of Substantially Equivalent on June 13, 2018. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Siemens Medi Cal Solutions, Inc. has at least 10 other 510(k) clearances on record.