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FDA 510(k) Application Details - K081109
Device Classification Name
System, Image Processing, Radiological
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510(K) Number
K081109
Device Name
System, Image Processing, Radiological
Applicant
BARCOVIEW, MEDICAL IMAGING SYSTEMS
35 PRESIDENT KENNEDYPARK
KORTRIJK B-8500 BE
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Contact
NEIL PHILLIPS
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Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
04/18/2008
Decision Date
05/02/2008
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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