FDA-Device2014-05-28Class II
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Fujifilm Medical System USA, Inc.
Hazard
The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2.
Sold states
Worldwide Distribution - US Distribution including the states of TX and KY and Internationally to China.
Affected count
14
Manufactured in
419 West Ave, N/A, Stamford, CT, United States
Products
MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1642-2014Don't want to check this manually?
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