510(k) K042397

SCANX 14 by Air Techniques, Inc. — Product Code MQB

K042397 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "SCANX 14". The FDA issued a decision of Substantially Equivalent on October 5, 2004. 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. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.