FDA-Device2021-07-21Class II
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
Canon Medical System, USA, INC.
Hazard
The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.
Sold states
US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Manufactured in
2441 Michelle Dr, Tustin, CA, United States
Products
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2021Don't want to check this manually?
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