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FDA 510(k) Application Details - K132610
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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