510(k) K240465

O-arm O2 Imaging System by Medtronic Navigation, Inc. — Product Code OWB

K240465 is an FDA 510(k) premarket notification submitted by Medtronic Navigation, Inc. for the device "O-arm O2 Imaging System". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Medtronic Navigation, Inc. has at least 10 other 510(k) clearances on record.