510(k) K833237

DIGITAL RADIOGRAPHY SYS DUAL GANTRIES by American Science and Engineering, Inc. — Product Code JAA

K833237 is an FDA 510(k) premarket notification submitted by American Science and Engineering, Inc. for the device "DIGITAL RADIOGRAPHY SYS DUAL GANTRIES". The FDA issued a decision of Substantially Equivalent on December 8, 1983. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. American Science and Engineering, Inc. has at least 2 other 510(k) clearances on record.