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FDA 510(k) Application Details - K111758
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K111758
Device Name
System, Image Processing, Radiological
Applicant
DOG MICROSYSTEMS, INC.
116 PRINCIPALE
SUITE 200
GRANBY, QUEBEC J2G 2V2 CA
Other 510(k) Applications for this Company
Contact
FLORENT CHANDELIER
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
06/22/2011
Decision Date
02/14/2012
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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