FDA 510(k) Application Details - K140920

Device Classification Name Colon Computed Tomography System, Computer Aided Detection

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510(K) Number K140920
Device Name Colon Computed Tomography System, Computer Aided Detection
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PARKWAY
MALVEN, PA 19355 US
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Contact KIMBERLY MANGUM
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Regulation Number 892.2050

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Classification Product Code NWE
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Date Received 04/10/2014
Decision Date 12/03/2014
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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