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FDA 510(k) Application Details - K143196
Device Classification Name
Lung Computed Tomography System, Computer-Aided Detection
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510(K) Number
K143196
Device Name
Lung Computed Tomography System, Computer-Aided Detection
Applicant
SIEMENS AG MEDICAL SOLUTIONS
20 VALLEY STREAM PARKWAY
MALVERN, PA 19355 US
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Contact
JAMES E KUHN JR.
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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
11/06/2014
Decision Date
05/12/2015
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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