510(k) K203428

Ziehm Vision RFD by Ziehm Imaging GmbH — Product Code JAA

K203428 is an FDA 510(k) premarket notification submitted by Ziehm Imaging GmbH for the device "Ziehm Vision RFD". The FDA issued a decision of Substantially Equivalent on March 17, 2021. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Ziehm Imaging GmbH has at least 10 other 510(k) clearances on record.