510(k) K802888

RAYTHEON MEDICAL IMAGING by Machlett Laboratories, Inc. — Product Code IXL

K802888 is an FDA 510(k) premarket notification submitted by Machlett Laboratories, Inc. for the device "RAYTHEON MEDICAL IMAGING". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Machlett Laboratories, Inc. has at least 3 other 510(k) clearances on record.