510(k) K181403

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR by GE Healthcare — Product Code OWB

K181403 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR". The FDA issued a decision of Substantially Equivalent on Nov 2, 2018. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. GE Healthcare has 168 other 510(k) clearances on record.