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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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