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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 St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Eos Imaging
555 Thirteenth St. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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