510(k) K130377

KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM by Medicatech USA — Product Code MQB

K130377 is an FDA 510(k) premarket notification submitted by Medicatech USA for the device "KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 17, 2013. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Medicatech USA has at least 9 other 510(k) clearances on record.