FDA-Device2015-01-21Class II

SOMATOM Force; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.

Siemens Medical Solutions USA, Inc
Hazard

Artifacts are found in acquired imaging on the SOMATOM Force.

Sold states
PA, MA, MN, SC, MD, and TX.
Affected count
7
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
SOMATOM Force; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2015

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