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510(k) K140920

SYNGO.CT COLONOGRAPHY by Siemens Medical Solutions USA, Inc. — Product Code NWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2014
Date Received
April 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colon Computed Tomography System, Computer Aided Detection
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.

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Other clearances for product code NWE

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