510(k) K083048

NEORAY DR 2520 DIGITAL IMAGING SYSTEM by Portavision Medical, LLC — Product Code IZL

K083048 is an FDA 510(k) premarket notification submitted by Portavision Medical, LLC for the device "NEORAY DR 2520 DIGITAL IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 21, 2008. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Portavision Medical, LLC has at least 5 other 510(k) clearances on record.