510(k) K191623

ScanX Touch/ScanX Duo Touch by Air Techniques, Inc. — Product Code MUH

K191623 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "ScanX Touch/ScanX Duo Touch". The FDA issued a decision of Substantially Equivalent on August 21, 2019. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.