510(k) K110801

WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM by Direct Digital Imaging Technology (Beijing), Inc. — Product Code MQB

K110801 is an FDA 510(k) premarket notification submitted by Direct Digital Imaging Technology (Beijing), Inc. for the device "WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 2, 2011. 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.