510(k) K162568

INTRABEAM 600 by Carl Zeiss Meditec, AG — Product Code JAD

K162568 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "INTRABEAM 600". The FDA issued a decision of Substantially Equivalent on December 15, 2016. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.