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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K120721
Device Name EOS
Original Applicant
EOS IMAGING
555 thirteenth street, nw
washington,  DC  20004
Original Contact john j smith
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/08/2012
Decision Date 04/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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