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FDA 510(k) Application Details - K111164
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K111164
Device Name
System, Image Processing, Radiological
Applicant
CLIENT OUTLOOK INC
295 HAGEY BLVD
WATERLOO N2L 6R5 CA
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Contact
CHRISTIE EBY
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
04/26/2011
Decision Date
05/06/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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