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510(k) K153464

FDR D-EVO flat Panel Detector System by Fujifilm Medical Systems U.S.A, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2016
Date Received
December 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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