510(k) K241174

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) by Carl Zeiss Meditec, AG — Product Code JAD

K241174 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)". The FDA issued a decision of Substantially Equivalent on January 10, 2025. 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.