510(k) K122842

RADREX-I, SW V4.00 MODEL DRAD-3000E by Toshiba America Medical Systems, In.C — Product Code MQB

K122842 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "RADREX-I, SW V4.00 MODEL DRAD-3000E". The FDA issued a decision of Substantially Equivalent on October 9, 2012. 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. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.