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FDA 510(k) Application Details - K043617
Device Classification Name
Lung Computed Tomography System, Computer-Aided Detection
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510(K) Number
K043617
Device Name
Lung Computed Tomography System, Computer-Aided Detection
Applicant
HOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730 US
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Contact
ARTHUR FRIEDMAN
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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
11/26/2007
Decision Date
12/21/2007
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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