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FDA 510(k) Application Details - K101796
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K101796
Device Name
System, Image Processing, Radiological
Applicant
IEI TECHNOLOGY CORP.
#6, LANE 29, WENMING ROAD
GUISHAN, TAOYUAN 33383 TW
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Contact
HUI-CHEN KAI
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
06/28/2010
Decision Date
07/15/2010
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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