510(k) K111551

OEC(R) 9800, OEC(R) 9800 PLUS by Ge Oec Medical Systems, Inc. — Product Code OWB

K111551 is an FDA 510(k) premarket notification submitted by Ge Oec Medical Systems, Inc. for the device "OEC(R) 9800, OEC(R) 9800 PLUS". The FDA issued a decision of Substantially Equivalent on October 4, 2011. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Ge Oec Medical Systems, Inc. has at least 10 other 510(k) clearances on record.