510(k) K921116

PX-100 PORTABLE X-RAY GENERATOR by Acoma Medical Imaging, Inc. — Product Code IZL

K921116 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "PX-100 PORTABLE X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.