510(k) K812217

FLUORO AUTOMATIC BRIGHTNESS SYS by Keystone X-Ray, Inc. — Product Code JAA

K812217 is an FDA 510(k) premarket notification submitted by Keystone X-Ray, Inc. for the device "FLUORO AUTOMATIC BRIGHTNESS SYS". The FDA issued a decision of Substantially Equivalent on September 16, 1981. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Keystone X-Ray, Inc. has at least 3 other 510(k) clearances on record.