510(k) K942367

AXT 1400 SPOTFILM DEVICE by Applied X-Ray Technologies, Inc. — Product Code IXL

K942367 is an FDA 510(k) premarket notification submitted by Applied X-Ray Technologies, Inc. for the device "AXT 1400 SPOTFILM DEVICE". The FDA issued a decision of Substantially Equivalent on June 6, 1994. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Applied X-Ray Technologies, Inc. has at least 2 other 510(k) clearances on record.