FDA-Device2015-05-13Class II
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use o
Siemens Medical Solutions USA, Inc
Hazard
If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
Sold states
Nationwide Distribution.
Affected count
43
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2015Don't want to check this manually?
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