510(k) K031633

CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C by Canon USA, Inc. — Product Code MQB

K031633 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C". The FDA issued a decision of Substantially Equivalent on June 11, 2003. 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. Canon USA, Inc. has at least 10 other 510(k) clearances on record.