510(k) K090062

WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM by Direct Digital Imaging Technology (Beijing), Inc. — Product Code MQB

K090062 is an FDA 510(k) premarket notification submitted by Direct Digital Imaging Technology (Beijing), Inc. for the device "WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 18, 2009. 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. Direct Digital Imaging Technology (Beijing), Inc. has 1 other 510(k) clearance on record.