510(k) K827489

HYPERLUX 30 IMAGE SYSTEM by Cgr Medical Corp. — Product Code JAA

K827489 is an FDA 510(k) premarket notification submitted by Cgr Medical Corp. for the device "HYPERLUX 30 IMAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 4, 1982. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Cgr Medical Corp. has at least 10 other 510(k) clearances on record.