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FDA 510(k) Application Details - K162141
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K162141
Device Name
System, Image Processing, Radiological
Applicant
XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD.
Rm. A608, Pioneering Square, No. 48 Keji Rd.,
Gaoxin Dist.
Xi'an 710075 CN
Other 510(k) Applications for this Company
Contact
Echo Chou
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
08/01/2016
Decision Date
09/02/2016
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
N
Expedited Review
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