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510(k) K131408

CR 12-X DIGITIZER by Agfa Healthcare N.V. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2013
Date Received
May 15, 2013
Clearance Type
Special
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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