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FDA 510(k) Application Details - K013922
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K013922
Device Name
System, Image Processing, Radiological
Applicant
BARCO NV
P.O. BOX 12038
LA JOLLA, CA 92039-2038 US
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Contact
FRANK FERGUSON
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
11/27/2001
Decision Date
01/28/2002
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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