510(k) K950317

ADVANTX 1824 SPOTFILM DEVICE by GE Medical Systems — Product Code IXL

K950317 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "ADVANTX 1824 SPOTFILM DEVICE". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. GE Medical Systems has at least 10 other 510(k) clearances on record.