FDA 510(k), K132261, DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

FDA 510(k), K132261, DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

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510(K) Number: K132261
Device Name: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
Manufacturer: GE MEDICAL SYSTEMS, LLC
Device Classification Name: system, x-ray, tomographic
Regulation Number: 892.1740
Classification Product Code: IZF
Date Received: 07/19/2013
Decision Date: 11/18/2013
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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