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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K052403
Device Name CORONIS 2MP-21 AND MFGD 2621
Applicant
Barcoview
35 President Kennedypark
Kortrijk,  BE B-8500
Applicant Contact LIEVEN DE WANDEL
Correspondent
Barcoview
35 President Kennedypark
Kortrijk,  BE B-8500
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/01/2005
Decision Date 09/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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