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FDA 510(k), K083423, COLONCAD API 3.1
FDA 510(k), K083423, COLONCAD API 3.1
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510(K) Number: K083423
Device Name: COLONCAD API 3.1
Manufacturer: MEDICSIGHT PLC
Device Classification Name: colon computed tomography system, computer aided detection
Regulation Number: 892.2050
Classification Product Code: NWE
Date Received: 11/19/2008
Decision Date: 05/17/2011
Regulation Medical Specialty: Radiology
Device Name: COLONCAD API 3.1
Manufacturer: MEDICSIGHT PLC
Device Classification Name: colon computed tomography system, computer aided detection
Regulation Number: 892.2050
Classification Product Code: NWE
Date Received: 11/19/2008
Decision Date: 05/17/2011
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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