FDA-Device2016-12-21Class II
SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
Siemens Medical Solutions USA, Inc
Hazard
Software update that provides software and firmware bug-fixes to improve system performance
Sold states
Nationwide Distribution
Affected count
104 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2017Don't want to check this manually?
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