510(k) K232344

Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR by GE Medical Systems SCS — Product Code OWB

K232344 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR". The FDA issued a decision of Substantially Equivalent on October 11, 2023. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.