510(k) K790443

PORTABLE X-RAY UNIT by General X-Ray, Inc. — Product Code IZL

K790443 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "PORTABLE X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on March 26, 1979. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.