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FDA 510(k) Application Details - K053162
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K053162
Device Name
System, Image Processing, Radiological
Applicant
VOLUME INTERACTIONS PTE LTD
1 KIM SENG PROMENADE
#12-01 GREAT WORLD CITY EAST
TOWER, SINGAPORE 237994 SG
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Contact
R. FAREETH
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
11/14/2005
Decision Date
12/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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