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FDA 510(k) Application Details - K070831
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K070831
Device Name
System, Image Processing, Radiological
Applicant
BARCOVIEW MIS EDINBURGH
BONNINGTON BOND, 2 ANDERSON PL
EDINBURGH, LOTHIAN EH6 5NP GB
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Contact
NEIL PHILLIPS
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2007
Decision Date
05/22/2007
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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