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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
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
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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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