FDA-Device2015-05-13Class II
EOS, Digital radiography system used in general radiographic examinations.
Eos Imaging Inc
Hazard
When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
Sold states
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
Affected count
13 units installed in US
Manufactured in
185 Alewife Brook Pkwy Ste 410, N/A, Cambridge, MA, United States
Products
EOS, Digital radiography system used in general radiographic examinations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1460-2015Don't want to check this manually?
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