510(k) K121653

INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS by Carl Zeiss Meditec, Inc. — Product Code JAD

K121653 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS". The FDA issued a decision of Substantially Equivalent on December 27, 2012. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.