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FDA 510(k), K103792, BARCO MAMMO TOMOSYNTHESIS
FDA 510(k), K103792, BARCO MAMMO TOMOSYNTHESIS
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510(K) Number: K103792
Device Name: BARCO MAMMO TOMOSYNTHESIS
Manufacturer: BARCO NV
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 12/27/2010
Decision Date: 03/04/2011
Regulation Medical Specialty: Radiology
Device Name: BARCO MAMMO TOMOSYNTHESIS
Manufacturer: BARCO NV
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 12/27/2010
Decision Date: 03/04/2011
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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