FDA 510(k) Application Details - K133663

Device Classification Name System, Image Processing, Radiological

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510(K) Number K133663
Device Name System, Image Processing, Radiological
Applicant BARCO N.V.
35 PRESIDENT KENNEDYPARK
KORTRIJK 8500 BE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/29/2013
Decision Date 03/25/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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