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510(k) K121095

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2012
Date Received
April 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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