FDA 510(k) Application Details - K041807

Device Classification Name Lung Computed Tomography System, Computer-Aided Detection

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510(K) Number K041807
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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Date Received 07/06/2004
Decision Date 07/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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