FDA 510(k) Application Details - K130772

Device Classification Name System, Image Processing, Radiological

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510(K) Number K130772
Device Name System, Image Processing, Radiological
Applicant NEC DISPLAY SOLUTIONS, LTD.
1F, # 181, S. 2, WUNHUA 1ST RD
LINKOU TOWNSHIP
TAIPEI 24447 TW
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Contact ANGUS HSU
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 03/20/2013
Decision Date 04/18/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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