FDA-Device2013-06-12Class II
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
AGFA Corp.
Hazard
Customers could potentially experience intermittent, unintended and illogical movement when using the product.
Sold states
Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada
Affected count
104
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2013Don't want to check this manually?
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