510(k) K073670

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 by Orex Computed Radiography, Ltd. — Product Code MQB

K073670 is an FDA 510(k) premarket notification submitted by Orex Computed Radiography, Ltd. for the device "KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260". The FDA issued a decision of Substantially Equivalent on January 25, 2008. 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. Orex Computed Radiography, Ltd. has at least 2 other 510(k) clearances on record.