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510(k) K122736

DX-D IMAGING PACKAGE by Agfa Healthcare N.V. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2013
Date Received
September 19, 2012
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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