FDA-Device2016-10-19Class II
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Medtronic Navigation, Inc.-Littleton
Hazard
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Sold states
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
Affected count
14 units
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2017Don't want to check this manually?
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