FDA-Device2012-09-05Class II

EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.

Toshiba American Medical Systems Inc
Hazard

The status display in the sequence queue window may not change from "Current" to "Done".

Sold states
Nationwide Distribution
Affected count
54
Manufactured in
2441 Michelle Dr, P.O. Box 2068, Tustin, CA, United States
Products
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2012

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