510(k) K101289

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB by Air Techniques, Inc. — Product Code MQB

K101289 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB". The FDA issued a decision of Substantially Equivalent on August 3, 2010. 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.