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510(k) K132261

DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) by Ge Medical Systems, LLC — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2013
Date Received
July 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

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