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FDA 510(k), K140920, SYNGO.CT COLONOGRAPHY
FDA 510(k), K140920, SYNGO.CT COLONOGRAPHY
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510(K) Number: K140920
Device Name: SYNGO.CT COLONOGRAPHY
Manufacturer: KIMBERLY MANGUM
Device Classification Name: Colon Computed Tomography System, Computer Aided Detection
Regulation Number: NWE
Classification Product Code: 04/10/2014
Date Received: 12/03/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SYNGO.CT COLONOGRAPHY
Manufacturer: KIMBERLY MANGUM
Device Classification Name: Colon Computed Tomography System, Computer Aided Detection
Regulation Number: NWE
Classification Product Code: 04/10/2014
Date Received: 12/03/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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