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FDA 510(k) Application Details - K033412
Device Classification Name
Lung Computed Tomography System, Computer-Aided Detection
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510(K) Number
K033412
Device Name
Lung Computed Tomography System, Computer-Aided Detection
Applicant
MEDICSIGHT
46 BERKELEY SQUARE
LONDON W 1J 5AT GB
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Contact
CAROL MACDONALD
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Regulation Number
892.2050
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Classification Product Code
OEB
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More FDA Info for this Product Code
Date Received
10/27/2003
Decision Date
12/30/2003
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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