510(k) K132261

DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) by Ge Medical Systems, LLC — Product Code IZF

K132261 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)". The FDA issued a decision of Substantially Equivalent on November 18, 2013. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.