510(k) K200396

Insight Enhanced DRF Digital Imaging System by Imaging Engineering, LLC — Product Code JAA

K200396 is an FDA 510(k) premarket notification submitted by Imaging Engineering, LLC for the device "Insight Enhanced DRF Digital Imaging System". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Imaging Engineering, LLC has at least 3 other 510(k) clearances on record.