FDA 510(k) Application Details - K132610

Device Classification Name System, Image Processing, Radiological

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510(K) Number K132610
Device Name System, Image Processing, Radiological
Applicant SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD
RM 201, INCUBATOR BUILDING, CASTD,
HIGH-TECH SOUTH 1ST ST.
SHENZHEN 518057 CN
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Contact WU QIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 08/20/2013
Decision Date 09/04/2013
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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