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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 K123740
Device Name EOS
Applicant
EOS IMAGING
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
EOS IMAGING
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/05/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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