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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 K131408
Device Name CR 12-X DIGITIZER
Applicant
Agfa Healthcare N.V.
10 S. Academy St.
Greenville,  SC  29601
Applicant Contact SHAEANN CAVANAGH
Correspondent
Agfa Healthcare N.V.
10 S. Academy St.
Greenville,  SC  29601
Correspondent Contact SHAEANN CAVANAGH
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/15/2013
Decision Date 08/29/2013
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
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